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Found 9 results
510(k) Data Aggregation
K Number
K974479Device Name
SILIMED VAGINAL STENT
Manufacturer
SILIMED, LLC.
Date Cleared
1998-08-05
(252 days)
Product Code
KXP
Regulation Number
884.3900Why did this record match?
Applicant Name (Manufacturer) :
SILIMED, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silimed Vaginal Stent is designed to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.
The surgeon is responsible for proper choice of size to meet the clinical and aesthetic needs of each case.
Device Description
Silimed Vaginal Stent
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K Number
K981852Device Name
SILIMED TISSUE EXPANDER
Manufacturer
SILIMED, LLC.
Date Cleared
1998-08-05
(71 days)
Product Code
LCJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SILIMED, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silimed Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.
Device Description
Not Found
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K Number
K981835Device Name
SILIMED MALAR IMPLANT
Manufacturer
SILIMED, LLC.
Date Cleared
1998-07-09
(44 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SILIMED, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silimed Malar Implant is designed to be used for augmentation and reconstruction of the cheek.
Device Description
Not Found
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K Number
K981850Device Name
SILIMED CHIN IMPLANTS
Manufacturer
SILIMED, LLC.
Date Cleared
1998-07-09
(44 days)
Product Code
FWP
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SILIMED, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silimed Chin Implants are intended for use in aesthetic, corrective or reconstructive surgery of the chin.
Device Description
Not Found
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K Number
K981851Device Name
SILIMED SILICONE CARVING BLOCK
Manufacturer
SILIMED, LLC.
Date Cleared
1998-07-09
(44 days)
Product Code
MIB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SILIMED, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silimed Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.
Device Description
Silimed Silicone Carving Blocks
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K Number
K981833Device Name
SILIMED NASAL L SHAPED IMPLANT
Manufacturer
SILIMED, LLC.
Date Cleared
1998-06-26
(31 days)
Product Code
FZE
Regulation Number
878.3680Why did this record match?
Applicant Name (Manufacturer) :
SILIMED, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silimed Nasal Implant is designed to be used for augmentation and reconstruction of the nasal contour. It is radiopaque and may be trimmed.
Device Description
Silimed Nasal "L" Shaped Implant
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K Number
K980221Device Name
SILIMED NASAL RETAINER
Manufacturer
SILIMED, LLC.
Date Cleared
1998-04-02
(70 days)
Product Code
LYA
Regulation Number
874.4780Why did this record match?
Applicant Name (Manufacturer) :
SILIMED, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silimed Nasal Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty and/or primary and secondary rhinocheiloplasty (cleft-lip nose patients).
Device Description
The Silimed Nasal Retainer was designed for prophylaxis of stenosis and cicatricial structures. It is recommended for all age groups, and for any type of nose. It has a functional format and can be sectioned by adjusting the length according to the requirement. The Silimed Nasal Retainer is composed of chemically and mechanically resistance silicone elastomer (HCRA 35M). The elastomer is soft, smooth of surface and contains a defined volume of elastomer whose shape, density and overall consistency have been chosen to replace human tissue. It has a defined length, width and circumference for the two channels that form the opening for the right and left nostril. The advantages of the Silimed Nasal Retainer are: 1) maintains the septum in a vertical position, 2) allows for nasal breathing immediately after the operation, without blocking air flow, 3) painless and non-traumatic, 4) easy to keep clean and 5) single patient use. The Silimed Nasal Retainer is available in 13 sizes. Silimed's Nasal Retainer is sterilized by ethylene oxide. The method of sterilization is shown on the package, which is a double peel pouch. An individual confirmation of each batch is carried out, as well as a quarterly confirmation by an independent laboratory.
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K Number
K974480Device Name
SILIMED CALF IMPLANT
Manufacturer
SILIMED, LLC.
Date Cleared
1998-02-24
(90 days)
Product Code
MIB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SILIMED, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimod Silicone Carving Block allows the surgeon to carve a finished device for his own custom uso.
Device Description
Silicone Carving Blocks
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K Number
K974482Device Name
SILIMED GLUTEAL IMPLANT
Manufacturer
SILIMED, LLC.
Date Cleared
1998-02-24
(90 days)
Product Code
MIB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SILIMED, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silicone Carving Block is designed to be used in acsthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.
Device Description
Silicone Carving Blocks
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