K781534 is an FDA 510(k) clearance for the SURG-O-PAK PREP PAD. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Convertors (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978, 48 days after receiving the submission on September 6, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K781534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1978 |
| Decision Date | October 24, 1978 |
| Days to Decision | 48 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 |