The following data is part of a premarket notification filed by Gam Industries, Inc. with the FDA for Umbilical Clamp.
| Device ID | K915569 |
| 510k Number | K915569 |
| Device Name: | UMBILICAL CLAMP |
| Classification | Clamp, Umbilical |
| Applicant | GAM INDUSTRIES, INC. P.O. BOX 2226 Petersburg, VA 23804 -1526 |
| Contact | Gary J.beden |
| Correspondent | Gary J.beden GAM INDUSTRIES, INC. P.O. BOX 2226 Petersburg, VA 23804 -1526 |
| Product Code | HFW |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-12 |
| Decision Date | 1992-09-23 |