The following data is part of a premarket notification filed by Doctor's Research Group, Inc. with the FDA for Drg Disposable Vaginal Speculum.
| Device ID | K012535 |
| 510k Number | K012535 |
| Device Name: | DRG DISPOSABLE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | DOCTOR'S RESEARCH GROUP, INC. 143 WOLCOTT RD. Wolcott, CT 06716 |
| Contact | Richard Deslauriers |
| Correspondent | Richard Deslauriers DOCTOR'S RESEARCH GROUP, INC. 143 WOLCOTT RD. Wolcott, CT 06716 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-07 |
| Decision Date | 2002-03-01 |
| Summary: | summary |