The following data is part of a premarket notification filed by Roland J. Zwick, Inc. with the FDA for Cin-shear.
| Device ID | K840352 |
| 510k Number | K840352 |
| Device Name: | CIN-SHEAR |
| Classification | Forceps, Biopsy, Gynecological |
| Applicant | ROLAND J. ZWICK, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HFB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-26 |
| Decision Date | 1984-04-05 |