The following data is part of a premarket notification filed by Femspec L.l.c. with the FDA for Femspec Disposable Vaginal Speculum.
| Device ID | K041757 |
| 510k Number | K041757 |
| Device Name: | FEMSPEC DISPOSABLE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | FEMSPEC L.L.C. 220 HALLECK STREET, SUITE 120 P.O. BOX 29450 San Francisco, CA 94129 -0450 |
| Contact | Gerald Jay Sanders |
| Correspondent | Gerald Jay Sanders FEMSPEC L.L.C. 220 HALLECK STREET, SUITE 120 P.O. BOX 29450 San Francisco, CA 94129 -0450 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-29 |
| Decision Date | 2004-12-23 |
| Summary: | summary |