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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 K896150
Device Name IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC
Applicant
Teknar, Inc.
267 Wolfner Dr.
Fenton,  MO  63026
Applicant Contact KENNETH O HEAD
Correspondent
Teknar, Inc.
267 Wolfner Dr.
Fenton,  MO  63026
Correspondent Contact KENNETH O HEAD
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/23/1989
Decision Date 01/18/1990
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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