K920837 is an FDA 510(k) clearance for the STERILE CONVERTOR SAFECARE GOWN AND DRAPE. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Baxter Healthcare Corp (Waukegan, US). The FDA issued a Cleared decision on May 22, 1992, 88 days after receiving the submission on February 24, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K920837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1992 |
| Decision Date | May 22, 1992 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |