The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Gynaspyr Vacuum Curettage Unit.
| Device ID | K850312 |
| 510k Number | K850312 |
| Device Name: | GYNASPYR VACUUM CURETTAGE UNIT |
| Classification | System, Abortion, Vacuum |
| Applicant | ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington, DC 20007 |
| Contact | Chambord |
| Correspondent | Chambord ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington, DC 20007 |
| Product Code | HHI |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-25 |
| Decision Date | 1985-02-28 |