The following data is part of a premarket notification filed by Gynova, Llc with the FDA for G-spec Articulated Weighted Vaginal Speculum.
| Device ID | K052420 |
| 510k Number | K052420 |
| Device Name: | G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | GYNOVA, LLC 698 MIDDLE TNPK E Manchester, CT 06040 |
| Contact | Don Guinan |
| Correspondent | Don Guinan GYNOVA, LLC 698 MIDDLE TNPK E Manchester, CT 06040 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-02 |
| Decision Date | 2006-04-06 |
| Summary: | summary |