K881757 is an FDA 510(k) clearance for the RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on July 15, 1988, 81 days after receiving the submission on April 25, 1988.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K881757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1988 |
| Decision Date | July 15, 1988 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |