K941499 is an FDA 510(k) clearance for the KIT PAK DRESSING CHANGE TRAY. This device is classified as a Tape And Bandage, Adhesive (Class I - General Controls, product code KGX).
Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on July 20, 1994, 113 days after receiving the submission on March 29, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K941499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | March 29, 1994 |
| Decision Date | July 20, 1994 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |