K922348 is an FDA 510(k) clearance for the VALTRAC(R) INTRODUCER FORCEP. This device is classified as a Lamp, Fluorescein, Ac-powered (Class II - Special Controls, product code HJE).
Submitted by American Cyanamid Co. (Danbury, US). The FDA issued a Cleared decision on June 9, 1992, 21 days after receiving the submission on May 19, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K922348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1992 |
| Decision Date | June 09, 1992 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | HJE — Lamp, Fluorescein, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |