K902921 is an FDA 510(k) clearance for the RAYON NEUROLOGICAL SPONGE. This device is classified as a Neurosurgical Paddie (Class II - Special Controls, product code HBA).
Submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on September 18, 1990, 77 days after receiving the submission on July 3, 1990.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4700.
| 510(k) Number | K902921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1990 |
| Decision Date | September 18, 1990 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HBA — Neurosurgical Paddie |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4700 |