K822145 is an FDA 510(k) clearance for the COMPLETE. This device is classified as a Clip, Removable (skin) (Class I - General Controls, product code FZQ).
Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 22, 1982, 93 days after receiving the submission on July 21, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4320.
| 510(k) Number | K822145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1982 |
| Decision Date | October 22, 1982 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZQ — Clip, Removable (skin) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4320 |