K822065 is an FDA 510(k) clearance for the KAM SUCKER. This device is classified as a Instrument, Surgical, Disposable (Class I - General Controls, product code KDC).
Submitted by The Anspach Effort, Inc. (Walker, US). The FDA issued a Cleared decision on August 16, 1982, 33 days after receiving the submission on July 14, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K822065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1982 |
| Decision Date | August 16, 1982 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KDC — Instrument, Surgical, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |