K883424 is an FDA 510(k) clearance for the SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Intera Corp. (Chattanooga, US). The FDA issued a Cleared decision on September 6, 1988, 22 days after receiving the submission on August 15, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K883424 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1988 |
| Decision Date | September 06, 1988 |
| Days to Decision | 22 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 |