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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K834525
Device Name ANGIOSCAN FLO MAD SPECTRUM ANALYZER
Applicant
Unigon Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Unigon Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2880
Classification Product Code
JOP  
Date Received12/21/1983
Decision Date 05/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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