The following data is part of a premarket notification filed by American Cyanamid Co. with the FDA for Valtrac(r) Introducer Forcep.
| Device ID | K922348 |
| 510k Number | K922348 |
| Device Name: | VALTRAC(R) INTRODUCER FORCEP |
| Classification | Lamp, Fluorescein, Ac-powered |
| Applicant | AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Contact | Stephen J Tamsett |
| Correspondent | Stephen J Tamsett AMERICAN CYANAMID CO. ONE CASPER ST. Danbury, CT 06810 |
| Product Code | HJE |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-19 |
| Decision Date | 1992-06-09 |