The following data is part of a premarket notification filed by Adept-med Intl., Inc. with the FDA for Gravespec.
| Device ID | K935636 |
| 510k Number | K935636 |
| Device Name: | GRAVESPEC |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | ADEPT-MED INTL., INC. 5040 ROBERT J. MATHEWS PKWY. SUITE 1 BUILDING D El Dorado Hills, CA 95762 |
| Contact | Christine Quigley |
| Correspondent | Christine Quigley ADEPT-MED INTL., INC. 5040 ROBERT J. MATHEWS PKWY. SUITE 1 BUILDING D El Dorado Hills, CA 95762 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-23 |
| Decision Date | 1994-03-25 |