The following data is part of a premarket notification filed by Gps with the FDA for Hospital's Spec.
| Device ID | K974228 |
| 510k Number | K974228 |
| Device Name: | HOSPITAL'S SPEC |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | GPS 11 LOWELL RD. Port Washington, NY 11050 |
| Contact | Louis Pagliara |
| Correspondent | Louis Pagliara GPS 11 LOWELL RD. Port Washington, NY 11050 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1997-12-12 |