The following data is part of a premarket notification filed by Thomasville Medical Assoc. with the FDA for Disposable Plastic Vaginal Specula.
| Device ID | K926536 |
| 510k Number | K926536 |
| Device Name: | DISPOSABLE PLASTIC VAGINAL SPECULA |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | THOMASVILLE MEDICAL ASSOC. 935 COBBLESTONE COURT Alpharetta, GA 30201 |
| Contact | Thomas J Zinnanti |
| Correspondent | Thomas J Zinnanti THOMASVILLE MEDICAL ASSOC. 935 COBBLESTONE COURT Alpharetta, GA 30201 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-30 |
| Decision Date | 1994-02-25 |