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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name colposcope (and colpomicroscope)
510(k) Number K770697
Device Name COLPOSCOPE SYSTEM
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.1630
Classification Product Code
HEX  
Date Received04/15/1977
Decision Date 05/20/1977
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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