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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Punch, Biopsy
510(k) Number K875119
Device Name BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
Applicant
Advanced Diagnostic Medical Systems, Inc.
6905 Sierra Ct.
Dublin,  CA  94568
Applicant Contact J ALLSEBROOK
Correspondent
Advanced Diagnostic Medical Systems, Inc.
6905 Sierra Ct.
Dublin,  CA  94568
Correspondent Contact J ALLSEBROOK
Regulation Number876.1075
Classification Product Code
FCI  
Date Received12/15/1987
Decision Date 03/02/1988
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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