K882072 is an FDA 510(k) clearance for the ORTHOPAEDIC AND SPINAL RING CURRETTES. This device is classified as a Methyl Methacrylate For Aneurysmorrhaphy (Class II - Special Controls, product code JXH).
Submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on June 17, 1988, 31 days after receiving the submission on May 17, 1988.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5030.
| 510(k) Number | K882072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 1988 |
| Decision Date | June 17, 1988 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | JXH — Methyl Methacrylate For Aneurysmorrhaphy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5030 |