K881396 is an FDA 510(k) clearance for the OPERATING ROOM TOWELS -STERILE & NON-STERILE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by A Plus International, Inc. (La Puente, US). The FDA issued a Cleared decision on April 29, 1988, 25 days after receiving the submission on April 4, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K881396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1988 |
| Decision Date | April 29, 1988 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | KKX - Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |