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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K852862
Device Name CORNEO-GAGE TWO
Applicant
Sonogage, Inc.
20525 Byron Rd.
Shaker Hts.,  OH  44122
Applicant Contact ALEXANDER DYBBS
Correspondent
Sonogage, Inc.
20525 Byron Rd.
Shaker Hts.,  OH  44122
Correspondent Contact ALEXANDER DYBBS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/08/1985
Decision Date 01/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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