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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Forceps, Biopsy, Gynecological
510(k) Number K842112
Device Name TISCHLER CERVICAL BIOPSY PUNCH FORCEPS
Applicant
J. SKLAR MFG. CO., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
J. SKLAR MFG. CO., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.4530
Classification Product Code
HFB  
Date Received05/29/1984
Decision Date 07/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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