The following data is part of a premarket notification filed by Playtex Manufacturing Inc. with the FDA for Playtex Sport (unscented) ,(scented) With Odorshield.
| Device ID | K111684 |
| 510k Number | K111684 |
| Device Name: | PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PLAYTEX MANUFACTURING INC. 75 COMMERCE DRIVE Allendale, NJ 07401 |
| Contact | Pushpa Rao |
| Correspondent | Pushpa Rao PLAYTEX MANUFACTURING INC. 75 COMMERCE DRIVE Allendale, NJ 07401 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-15 |
| Decision Date | 2012-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20078300002172 | K111684 | 000 |
| 10078300082580 | K111684 | 000 |
| 20078300082570 | K111684 | 000 |
| 10078300082559 | K111684 | 000 |
| 10078300082542 | K111684 | 000 |
| 10078300002168 | K111684 | 000 |