K934630 is an FDA 510(k) clearance for the UNIVERSAL VIDEO/LASER ARM DRAPE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Hydro-Med Products, Inc. (Dallas, US). The FDA issued a Cleared decision on October 28, 1994, 399 days after receiving the submission on September 24, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K934630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1993 |
| Decision Date | October 28, 1994 |
| Days to Decision | 399 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |