The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Tischler Cervical Biopsy Punch Forceps.
Device ID | K842112 |
510k Number | K842112 |
Device Name: | TISCHLER CERVICAL BIOPSY PUNCH FORCEPS |
Classification | Forceps, Biopsy, Gynecological |
Applicant | J. SKLAR MFG. CO., 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 | 1984-05-29 |
Decision Date | 1984-07-03 |