Submission Details
| 510(k) Number | K822554 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 1982 |
| Decision Date | September 14, 1982 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
CEMENT EXTRACTION INSTRUMENTATION
Sep 1982
Decision
21d
Days
—
Risk
About This 510(k) Submission
K822554 is an FDA 510(k) clearance for the CEMENT EXTRACTION INSTRUMENTATION, submitted by Surgi-Quip Inc.U (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982, 21 days after receiving the submission on August 24, 1982. This device falls under the General & Plastic Surgery review panel.
Device Classification
| Product Code | — |
| Device Class | — |
Manufacturer
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