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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 K893035
Device Name OPHTHASCAN 'S' MINI-A
Applicant
Biophysic Medical, Inc.
2440 Estand Way
Pleasant Hill,  CA  94523
Applicant Contact DOUGLAS DONALDSON
Correspondent
Biophysic Medical, Inc.
2440 Estand Way
Pleasant Hill,  CA  94523
Correspondent Contact DOUGLAS DONALDSON
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/24/1989
Decision Date 06/12/1989
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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