K972506 is an FDA 510(k) clearance for the INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR. This device is classified as a Transilluminator, Ac-powered (Class II - Special Controls, product code HJM).
Submitted by Infinitech, Inc. (Chesterfield, US). The FDA issued a Cleared decision on October 1, 1997, 90 days after receiving the submission on July 3, 1997.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1945.
| 510(k) Number | K972506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1997 |
| Decision Date | October 01, 1997 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HJM — Transilluminator, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1945 |