K822108 is an FDA 510(k) clearance for the CEMENT-PICK. This device is classified as a Spatula, Surgical, General & Plastic Surgery (Class I - General Controls, product code GAF).
Submitted by Bio-Blitz, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 11, 1982, 23 days after receiving the submission on July 19, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K822108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1982 |
| Decision Date | August 11, 1982 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAF — Spatula, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |