K875383 is an FDA 510(k) clearance for the LAKE CATHETER CARE KITS (MODIFICATION). This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Lake Medical Products, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 9, 1988, 85 days after receiving the submission on December 15, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K875383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | December 15, 1987 |
| Decision Date | March 09, 1988 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |