Submission Details
| 510(k) Number | K900566 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 07, 1990 |
| Decision Date | May 03, 1990 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K900566 is an FDA 510(k) clearance for the RICHARD-ALLAN VESSEL LOOPS, a Instrument, Surgical, Disposable (Class I — General Controls, product code KDC), submitted by Richard-Allan Medical Ind., Inc. (Richland, US). The FDA issued a Cleared decision on May 3, 1990, 85 days after receiving the submission on February 7, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K900566 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 07, 1990 |
| Decision Date | May 03, 1990 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KDC — Instrument, Surgical, Disposable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |