The following data is part of a premarket notification filed by Gynescope Corp. with the FDA for Gynescope Monopolar Forceps And Electrodes.
| Device ID | K902658 |
| 510k Number | K902658 |
| Device Name: | GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | GYNESCOPE CORP. 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Scott C Marlow |
| Correspondent | Scott C Marlow GYNESCOPE CORP. 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-15 |
| Decision Date | 1990-09-19 |