The following data is part of a premarket notification filed by Gyneco, Inc. with the FDA for Gyne-shear Cervical Biopsy Instrument W/dispis Tip.
| Device ID | K852357 |
| 510k Number | K852357 |
| Device Name: | GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP |
| Classification | Forceps, Biopsy, Gynecological |
| Applicant | GYNECO, INC. 51 CHUBB WAY Branchburg, NJ 08876 |
| Contact | Jane Aoyagi |
| Correspondent | Jane Aoyagi GYNECO, INC. 51 CHUBB WAY Branchburg, NJ 08876 |
| Product Code | HFB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-03 |
| Decision Date | 1985-07-05 |