The following data is part of a premarket notification filed by Femspec L.l.c. with the FDA for Femspce-s Disposable Sterile Vaginal Speculum, Model St-i.
| Device ID | K052192 |
| 510k Number | K052192 |
| Device Name: | FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I |
| Classification | Speculum, Vaginal, Nonmetal |
| 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 | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-11 |
| Decision Date | 2006-02-02 |