The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Modification To Playtex Tampons #24002.
Device ID | K022882 |
510k Number | K022882 |
Device Name: | MODIFICATION TO PLAYTEX TAMPONS #24002 |
Classification | Tampon, Menstrual, Scented, Deodorized |
Applicant | PLAYTEX PRODUCTS, INC. 75 COMMERCE DR. Allendale, NJ 07401 -1600 |
Contact | Paul A Siracusa |
Correspondent | Paul A Siracusa PLAYTEX PRODUCTS, INC. 75 COMMERCE DR. Allendale, NJ 07401 -1600 |
Product Code | HIL |
CFR Regulation Number | 884.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-30 |
Decision Date | 2002-09-16 |
Summary: | summary |