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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, manual, general obstetric-gynecologic
510(k) Number K812204
Device Name UTERINE MANIPULATORS
Applicant
REZNIK INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
REZNIK INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.4520
Classification Product Code
KOH  
Date Received08/04/1981
Decision Date 10/13/1981
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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