K882281 is an FDA 510(k) clearance for the GOWN, ISOLATION, SURGICAL (FYC). This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by A Plus International, Inc. (La Puente, US). The FDA issued a Cleared decision on June 23, 1988, 23 days after receiving the submission on May 31, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K882281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1988 |
| Decision Date | June 23, 1988 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | FYC - Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |