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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 Doppler, Ultrasonic
510(k) Number K882755
Device Name MODEL 500V VASCULAR SPECTRUM ANALYZER
Applicant
Multigon Industries, Inc.
P.O. Box 2485
Mt. Vernon,  NY  10551
Applicant Contact WILLIAM STERN
Correspondent
Multigon Industries, Inc.
P.O. Box 2485
Mt. Vernon,  NY  10551
Correspondent Contact WILLIAM STERN
Regulation Number892.1550
Classification Product Code
IYN  
Date Received07/05/1988
Decision Date 11/29/1988
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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