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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K884900
Device Name SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER
Applicant
Siemens Medical Solutions USA, Inc.
5675 Gibraltar Dr.
Pleasanton,  CA  94566
Applicant Contact TERRILYNN K JOHNSON
Correspondent
Siemens Medical Solutions USA, Inc.
5675 Gibraltar Dr.
Pleasanton,  CA  94566
Correspondent Contact TERRILYNN K JOHNSON
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/23/1988
Decision Date 01/13/1989
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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