The following data is part of a premarket notification filed by Vitalcare Group, Inc. with the FDA for Vitalcare Disposable Vaginal Speculum.
| Device ID | K983716 |
| 510k Number | K983716 |
| Device Name: | VITALCARE DISPOSABLE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | VITALCARE GROUP, INC. 15800 N.W. 13TH AVE. Miami, FL 33169 |
| Contact | Ginger Talley |
| Correspondent | Ginger Talley VITALCARE GROUP, INC. 15800 N.W. 13TH AVE. Miami, FL 33169 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-21 |
| Decision Date | 1998-12-23 |