Search Results
Found 5 results
510(k) Data Aggregation
K Number
K983381Device Name
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
Manufacturer
Date Cleared
1998-10-19
(24 days)
Product Code
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
PARAGON TRADE BRANDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Paragon Trade Brands Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470)
Paragon Trade Brands Digital Tampons are made of a plug of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Device Description
Paragon Trade Brands Digital Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus.
These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord.
The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.
Ask a Question
Ask a specific question about this device
K Number
K981953Device Name
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
Manufacturer
Date Cleared
1998-08-18
(76 days)
Product Code
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
PARAGON TRADE BRANDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Paragon Menstrual Tampons are a plug made of cellulosic or synthetic material that is inserted into the vaginal and used to absorb menstrual or other vaginal discharge.
Device Description
Paragon Trade Brands Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus. These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord. The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.
Ask a Question
Ask a specific question about this device
K Number
K962953Device Name
DEODORANT PANTY SHIELD
Manufacturer
Date Cleared
1996-10-10
(72 days)
Product Code
Regulation Number
884.5425Why did this record match?
Applicant Name (Manufacturer) :
PARAGON TRADE BRANDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K962954Device Name
DEODORANT MAXI PAD
Manufacturer
Date Cleared
1996-10-10
(72 days)
Product Code
Regulation Number
884.5425Why did this record match?
Applicant Name (Manufacturer) :
PARAGON TRADE BRANDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K962962Device Name
DEODORANT PANTY LINER
Manufacturer
Date Cleared
1996-10-10
(72 days)
Product Code
Regulation Number
884.5425Why did this record match?
Applicant Name (Manufacturer) :
PARAGON TRADE BRANDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
Page 1 of 1