K880318 is an FDA 510(k) clearance for the ROVENSTEIN FORCEPS. This device is classified as a Forceps, Tube Introduction (Class I - General Controls, product code BWB).
Submitted by Eastmed Enterprises, Inc. (Marlton, US). The FDA issued a Cleared decision on March 21, 1988, 55 days after receiving the submission on January 26, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5780.
| 510(k) Number | K880318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1988 |
| Decision Date | March 21, 1988 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BWB — Forceps, Tube Introduction |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5780 |