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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 K890998
Device Name QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.
Applicant
Quantum Medical Systems, Inc.
1040 12th Ave.
Issaquah,  WA  98027
Applicant Contact TERRENCE J SWEENEY
Correspondent
Quantum Medical Systems, Inc.
1040 12th Ave.
Issaquah,  WA  98027
Correspondent Contact TERRENCE J SWEENEY
Regulation Number892.1550
Classification Product Code
IYN  
Date Received02/03/1989
Decision Date 05/02/1989
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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