K963391 is an FDA 510(k) clearance for the SPECULITE. This device is classified as a Source, Chemiluminescent Light (Class II - Special Controls, product code MPU).
Submitted by Trylon Corp. (Monarch Beach, US). The FDA issued a Cleared decision on December 12, 1997, 471 days after receiving the submission on August 28, 1996.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K963391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1996 |
| Decision Date | December 12, 1997 |
| Days to Decision | 471 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MPU — Source, Chemiluminescent Light |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |