K883822 is an FDA 510(k) clearance for the FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309. This device is classified as a Pad, Eye (Class I - General Controls, product code HMP).
Submitted by Consolidated Industries of Greater Syracuse, Inc. (Syracuse, US). The FDA issued a Cleared decision on November 22, 1988, 76 days after receiving the submission on September 7, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4440.
| 510(k) Number | K883822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | September 07, 1988 |
| Decision Date | November 22, 1988 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HMP — Pad, Eye |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4440 |