K840352 is an FDA 510(k) clearance for the CIN-SHEAR. This device is classified as a Forceps, Biopsy, Gynecological (Class I - General Controls, product code HFB).
Submitted by Roland J. Zwick, Inc. (Walker, US). The FDA issued a Cleared decision on April 5, 1984, 70 days after receiving the submission on January 26, 1984.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K840352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1984 |
| Decision Date | April 05, 1984 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HFB — Forceps, Biopsy, Gynecological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.4530 |