Submission Details
| 510(k) Number | K911637 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 1991 |
| Decision Date | August 02, 1991 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
K911637 is an FDA 510(k) clearance for the STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD, a Rongeur, Powered (Class II — Special Controls, product code HAD), submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on August 2, 1991, 113 days after receiving the submission on April 11, 1991. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4845.
| 510(k) Number | K911637 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 1991 |
| Decision Date | August 02, 1991 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HAD — Rongeur, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4845 |