K915569 is an FDA 510(k) clearance for the UMBILICAL CLAMP. This device is classified as a Clamp, Umbilical (Class II - Special Controls, product code HFW).
Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on September 23, 1992, 286 days after receiving the submission on December 12, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K915569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1991 |
| Decision Date | September 23, 1992 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HFW — Clamp, Umbilical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |