The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Rudd-clinic Hemorrhoidal Forceps.
| Device ID | K800441 |
| 510k Number | K800441 |
| Device Name: | RUDD-CLINIC HEMORRHOIDAL FORCEPS |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | J. SKLAR MFG. CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-28 |
| Decision Date | 1980-04-08 |