The following data is part of a premarket notification filed by Paragon Trade Brands, Inc. with the FDA for Deodorant Panty Shield.
Device ID | K962953 |
510k Number | K962953 |
Device Name: | DEODORANT PANTY SHIELD |
Classification | Pad, Menstrual, Scented |
Applicant | PARAGON TRADE BRANDS, INC. 10 COMMERCE DR. Gaffney, SC 29340 |
Contact | Tony Silwanowicz |
Correspondent | Tony Silwanowicz PARAGON TRADE BRANDS, INC. 10 COMMERCE DR. Gaffney, SC 29340 |
Product Code | HHL |
CFR Regulation Number | 884.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-30 |
Decision Date | 1996-10-10 |