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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 K871536
Device Name OPHTHASONIC A-SCAN/ B-SCAN
Applicant
Teknar, Inc.
267 Wolfner Dr.
Fenton,  MO  63026
Applicant Contact ARTHUR BOLLINGER
Correspondent
Teknar, Inc.
267 Wolfner Dr.
Fenton,  MO  63026
Correspondent Contact ARTHUR BOLLINGER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/20/1987
Decision Date 08/26/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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