The following data is part of a premarket notification filed by Gyneco, Inc. with the FDA for Master Endomet Biopsy Kit W/plas Cure 3,4mm-4003,4.
| Device ID | K853216 |
| 510k Number | K853216 |
| Device Name: | MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| 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 | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-01 |
| Decision Date | 1986-04-02 |