K871628 is an FDA 510(k) clearance for the PALEX (R) OSTOMY. This device is classified as a Collector, Ostomy (Class I - General Controls, product code EXB).
Submitted by Industrias Palex C/O Dma Med-Chem Corp. (Great Neck, US). The FDA issued a Cleared decision on July 8, 1987, 72 days after receiving the submission on April 27, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K871628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1987 |
| Decision Date | July 08, 1987 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EXB — Collector, Ostomy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5900 |