The following data is part of a premarket notification filed by Gynemetrics, Inc. with the FDA for Menstrual Aspiration Kits.
| Device ID | K803210 |
| 510k Number | K803210 |
| Device Name: | MENSTRUAL ASPIRATION KITS |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | GYNEMETRICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-18 |
| Decision Date | 1981-01-28 |