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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 K834307
Device Name ULTRASOUND SCANNER XL
Applicant
Interad Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Interad Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/03/1983
Decision Date 02/21/1984
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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