K914600 is an FDA 510(k) clearance for the NEUROLOGICAL SPONGE. This device is classified as a Neurosurgical Paddie (Class II - Special Controls, product code HBA).
Submitted by I M, Inc. (Fairfield, US). The FDA issued a Cleared decision on December 30, 1992, 446 days after receiving the submission on October 11, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4700.
| 510(k) Number | K914600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1991 |
| Decision Date | December 30, 1992 |
| Days to Decision | 446 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HBA — Neurosurgical Paddie |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4700 |