K950559 is an FDA 510(k) clearance for the DIENER RETRIEVAL DEVICES, a Forceps, Biopsy, Non-electric (Class I — General Controls, product code FCL), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on February 16, 1995, 8 days after receiving the submission on February 8, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K950559 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 08, 1995 |
| Decision Date | February 16, 1995 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCL — Forceps, Biopsy, Non-electric |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.1075 |