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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K812206
Device Name LAPAROSCOPE
Applicant
Reznik Instruments
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Reznik Instruments
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.1720
Classification Product Code
HET  
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
Predetermined Change
Control Plan Authorized		 No
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