K864810 is an FDA 510(k) clearance for the LIDSPLINT. This device is classified as a Pad, Eye (Class I - General Controls, product code HMP).
Submitted by Precision Therapeutics, Inc. (Las Vegas, US). The FDA issued a Cleared decision on January 20, 1987, 42 days after receiving the submission on December 9, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4440.
| 510(k) Number | K864810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1986 |
| Decision Date | January 20, 1987 |
| Days to Decision | 42 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 |