The following data is part of a premarket notification filed by Geneva Laboratories, Inc. with the FDA for Gent-l-spec Dispos. Vaginal Speculum.
| Device ID | K830725 |
| 510k Number | K830725 |
| Device Name: | GENT-L-SPEC DISPOS. VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | GENEVA LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-08 |
| Decision Date | 1983-04-27 |