The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Playtex Sport Plastic, Playtex Sport Plastic Multipack Tampons.
| Device ID | K060981 |
| 510k Number | K060981 |
| Device Name: | PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PLAYTEX PRODUCTS, INC. 75 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Keith Edgett |
| Correspondent | Keith Edgett 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 | 2006-04-10 |
| Decision Date | 2006-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10078300099335 | K060981 | 000 |
| 10078300081514 | K060981 | 000 |
| 10078300081507 | K060981 | 000 |
| 10078300031809 | K060981 | 000 |
| 10078300031793 | K060981 | 000 |
| 10078300031755 | K060981 | 000 |
| 10078300031748 | K060981 | 000 |
| 10078300031250 | K060981 | 000 |
| 20078300031240 | K060981 | 000 |
| 10078300031236 | K060981 | 000 |
| 10078300026911 | K060981 | 000 |
| 10078300119033 | K060981 | 000 |
| 10078300119002 | K060981 | 000 |
| 10078300117343 | K060981 | 000 |
| 20078300117333 | K060981 | 000 |
| 20078300083539 | K060981 | 000 |
| 20078300083546 | K060981 | 000 |
| 20078300099233 | K060981 | 000 |
| 20078300099226 | K060981 | 000 |
| 20078300081368 | K060981 | 000 |
| 10078300081354 | K060981 | 000 |
| 10078300081118 | K060981 | 000 |
| 20078300081092 | K060981 | 000 |
| 10078300026034 | K060981 | 000 |
| 20078300002202 | K060981 | 000 |
| 10078300002199 | K060981 | 000 |
| 10078300002182 | K060981 | 000 |
| 10078300026652 | K060981 | 000 |
| 20078300082563 | K060981 | 000 |
| 10078300083563 | K060981 | 000 |
| 20078300083553 | K060981 | 000 |
| 20078300117326 | K060981 | 000 |