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510(k) Data Aggregation
K Number
K113772Device Name
HPR EMOLLIENT FOAM
Manufacturer
Date Cleared
2012-02-09
(49 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PRUGEN IP HOLDINGS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HPR™ Emollient Foam is indicated to manage and relieve the burning, itching and pain associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. HPRTM Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Device Description
HPR 114 Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPR™ Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The HPR™ Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.
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K Number
K113774Device Name
HPR PLUS EMOLLIENT FOAM
Manufacturer
Date Cleared
2012-02-09
(49 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PRUGEN IP HOLDINGS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HPRTM Plus Emollient Foam is indicated to manage and relieve the burning, itching and pain associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. HPRTM Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Device Description
HPR 114 Plus Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPRTM Plus Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The HPR " Plus Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.
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K Number
K110732Device Name
EMULSION SB
Manufacturer
Date Cleared
2011-06-03
(79 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PRUGEN IP HOLDINGS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Emulsion SBTM is intended to be used as a topical skin care preparation applied at least twice daily to affected areas of the skin to improve dry skin conditions and to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment.
Device Description
Emulsion SB 100 is a non-sterile, viscous, lipid rich emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in a 90 gm tube.
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K Number
K093156Device Name
PRUCLAIR NONSTEROIDAL CREAM
Manufacturer
Date Cleared
2010-06-24
(261 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PRUGEN IP HOLDINGS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Under the supervision of a healthcare professional, PruClair™ non-steroidal cream is indicated to manage various types of dermatoses.
PruClair™ non-steroidal cream is indicated for minor burns, minor lacerations, and minor irritations.
Device Description
PruClair™ non-steroidal cream is a non-sterile, viscous emulsion/formulation, which is presented for both Prescription (requiring a physician diagnosis disease state) and over-the-counter (OTC) use.
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K Number
K093159Device Name
PR CREAM
Manufacturer
Date Cleared
2010-06-24
(261 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PRUGEN IP HOLDINGS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PR™ cream is indicated to manage various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. PR™ cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
PR™ cream is a non-sterile cream formulation intended for topical use only. It is presented for Prescription (requiring a physician diagnosis disease state) use. PRTM cream is or topical dermatologic use only. PR™ cream is applied in a thin layer to affected areas 2-3 times per day or as directed by a physician. PRTM cream is a nonsteroidal cream comprised of aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol, cyclomethicone, hexyl laurate, polyglyceryl-4-isostearate, prified water, and sodium chloride. Contains phenoxyethanol and propylparaben as preservatives.
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K Number
K092878Device Name
PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE
Manufacturer
Date Cleared
2010-01-15
(119 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PRUGEN IP HOLDINGS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PruTect™ is a water-based emulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, Ist and 2nd degree burns, including sunburns, and radiation dermatis. When applied properly to a wound, PruTect™ provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.
PruTectTM is indicated for use in:
- · Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers
- · Superficial Wounds
- · 1st and 2nd Degree Burns, including Sunburns
- · Dermal Donor and Graft Site Management
- · Radiation Dermatitis
- · Minor Abrasio»
Device Description
PruTect™ Topical Emulsion is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in both 45 gm and 90 gm tube formats.
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