K884290 is an FDA 510(k) clearance for the BAXTER DISPOSABLE CIRCUMCISION TRAY. This device is classified as a Clamp, Circumcision (Class II - Special Controls, product code HFX).
Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on December 8, 1988, 57 days after receiving the submission on October 12, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K884290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | October 12, 1988 |
| Decision Date | December 08, 1988 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HFX — Clamp, Circumcision |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |