K911606 is an FDA 510(k) clearance for the BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES. This device is classified as a Kit, Surgical Instrument, Disposable (Class I - General Controls, product code KDD).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on July 9, 1991, 90 days after receiving the submission on April 10, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K911606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | April 10, 1991 |
| Decision Date | July 09, 1991 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KDD — Kit, Surgical Instrument, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |