The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Playtex Deodorant Tampons, Model 34802.
Device ID | K020200 |
510k Number | K020200 |
Device Name: | PLAYTEX DEODORANT TAMPONS, MODEL 34802 |
Classification | Tampon, Menstrual, Scented, Deodorized |
Applicant | PLAYTEX PRODUCTS, INC. 75 COMMERCE DR. Allendale, NJ 07401 -1600 |
Contact | Mark Rosengarten |
Correspondent | Mark Rosengarten PLAYTEX PRODUCTS, INC. 75 COMMERCE DR. Allendale, NJ 07401 -1600 |
Product Code | HIL |
CFR Regulation Number | 884.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-22 |
Decision Date | 2002-03-13 |
Summary: | summary |