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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 K896173
Device Name ULTRASCAN(R)
Applicant
Topical Delivery Systems
555 Industrial Dr.
Hartland,  WI  53029
Applicant Contact L SCHMIRLER
Correspondent
Topical Delivery Systems
555 Industrial Dr.
Hartland,  WI  53029
Correspondent Contact L SCHMIRLER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/25/1989
Decision Date 04/11/1990
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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