K875166 is an FDA 510(k) clearance for the PHARMASEAL STERILE UMBILICAL CORD CLAMP. This device is classified as a Corkscrew (Class I - General Controls, product code HWI).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on March 2, 1988, 76 days after receiving the submission on December 17, 1987.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K875166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1987 |
| Decision Date | March 02, 1988 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HWI — Corkscrew |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |