The following data is part of a premarket notification filed by Synemed, Inc. with the FDA for Synevac Vacuum Curettage Systems.
| Device ID | K813282 |
| 510k Number | K813282 |
| Device Name: | SYNEVAC VACUUM CURETTAGE SYSTEMS |
| Classification | System, Abortion, Vacuum |
| Applicant | SYNEMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HHI |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-17 |
| Decision Date | 1981-12-14 |