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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 K770896
Device Name COLPOSCOPE MODEL II
Applicant
DYNATECH CRYOMEDICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DYNATECH CRYOMEDICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.1630
Classification Product Code
HEX  
Date Received05/16/1977
Decision Date 06/03/1977
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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