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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 K893996
Device Name CUSIS ULTRASOUND SKIN IMAGING SYSTEM
Applicant
Stiefel Research Institute, Inc.
Oakhill,  NY  12460
Applicant Contact WILLIAM CARR
Correspondent
Stiefel Research Institute, Inc.
Oakhill,  NY  12460
Correspondent Contact WILLIAM CARR
Regulation Number892.1560
Classification Product Code
IYO  
Date Received06/05/1989
Decision Date 09/21/1989
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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