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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, Diagnostic
510(k) Number K903561
Device Name QUICK-CLIP NEEDLE GUIDE
Applicant
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Applicant Contact STEPHEN T JOHNSON
Correspondent
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Correspondent Contact STEPHEN T JOHNSON
Regulation Number892.1570
Classification Product Code
ITX  
Date Received08/07/1990
Decision Date 03/05/1991
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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