K971979 is an FDA 510(k) clearance for the PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Playtex Products, Inc. (Paramus, US). The FDA issued a Cleared decision on September 26, 1997, 120 days after receiving the submission on May 29, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K971979 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 29, 1997 |
| Decision Date | September 26, 1997 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIB — Speculum, Vaginal, Nonmetal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |