The following data is part of a premarket notification filed by Gynescope Corp. with the FDA for Croak Ovarian Biopsy Forcep.
| Device ID | K902049 |
| 510k Number | K902049 |
| Device Name: | CROAK OVARIAN BIOPSY FORCEP |
| Classification | Forceps, Biopsy, Gynecological |
| 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 | HFB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-07 |
| Decision Date | 1990-06-07 |