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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K882549
Device Name ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
Applicant
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Applicant Contact ROBERT J GALLAGHER
Correspondent
Acuson Corp.
1220 Charleston Rd.
Mountain View,  CA  94039
Correspondent Contact ROBERT J GALLAGHER
Regulation Number876.1075
Classification Product Code
FCG  
Date Received06/20/1988
Decision Date 07/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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