K925715 is an FDA 510(k) clearance for the RS OPTIGUARD GOWN & DRAPE MATERIAL. 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 11, 1993, 180 days after receiving the submission on November 12, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K925715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1992 |
| Decision Date | May 11, 1993 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |