The following data is part of a premarket notification filed by Fem Suite, L.l.c. with the FDA for Femten Cervical Tenaculum.
| Device ID | K062563 |
| 510k Number | K062563 |
| Device Name: | FEMTEN CERVICAL TENACULUM |
| Classification | Tenaculum, Uterine |
| Applicant | FEM SUITE, L.L.C. 1530 HOLCOMB STREET Port Townsend, WA 98368 |
| Contact | Carl Youngmann |
| Correspondent | Carl Youngmann FEM SUITE, L.L.C. 1530 HOLCOMB STREET Port Townsend, WA 98368 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-31 |
| Decision Date | 2007-05-18 |
| Summary: | summary |