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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 K020024
Device Name CARIS MINITOME BIOPSY INSTRUMENT
Applicant
Artemis Medical, Inc.
21021 Corsair Blvd.
Haywayd,  CA  94545
Applicant Contact ALLAN L ABATI
Correspondent
Artemis Medical, Inc.
21021 Corsair Blvd.
Haywayd,  CA  94545
Correspondent Contact ALLAN L ABATI
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/03/2002
Decision Date 04/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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