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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K880314
Device Name HYSTEROSCOPE AUTONOM 4992
Applicant
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Applicant Contact CHARLES GILL
Correspondent
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Correspondent Contact CHARLES GILL
Regulation Number884.1690
Classification Product Code
HIH  
Date Received01/26/1988
Decision Date 08/25/1988
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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