The following data is part of a premarket notification filed by Femspec L.l.c. with the FDA for Femtest Endometrial Suction Curette, Model Ft-1.
| Device ID | K051294 |
| 510k Number | K051294 |
| Device Name: | FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | FEMSPEC L.L.C. 1530 HOLCOMB STREET Port Townsend, WA 98368 |
| Contact | Carl Youngmann |
| Correspondent | Carl Youngmann FEMSPEC L.L.C. 1530 HOLCOMB STREET Port Townsend, WA 98368 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-18 |
| Decision Date | 2005-12-21 |