K953638 is an FDA 510(k) clearance for the O.B. APPLICATOR TAMPONS, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on October 20, 1995, 77 days after receiving the submission on August 4, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.
| 510(k) Number | K953638 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 04, 1995 |
| Decision Date | October 20, 1995 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIL — Tampon, Menstrual, Scented, Scented-deodorized |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5460 |
| Definition | A Scented Or Scented-deodorized Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge. |