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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, Obstetric
510(k) Number K881263
Device Name MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
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 Number884.2960
Classification Product Code
HGL  
Date Received03/24/1988
Decision Date 01/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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