K921349 is an FDA 510(k) clearance for the STERILE,DISPOSABLE EYE DRESSING. This device is classified as a Pad, Eye (Class I - General Controls, product code HMP).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on May 29, 1992, 71 days after receiving the submission on March 19, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4440.
| 510(k) Number | K921349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1992 |
| Decision Date | May 29, 1992 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | HMP — Pad, Eye |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4440 |