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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 K801730
Device Name KRYMED SYSTEM 4001 TILT SCOPE
Applicant
Cryomedics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cryomedics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number884.1630
Classification Product Code
HEX  
Date Received07/25/1980
Decision Date 08/13/1980
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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