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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 K032847
Device Name EXCISOR BIOPTOME, MODEL 01-0004
Applicant
Acueity, Inc.
100 Hamilton Ave., Suite 140
Palo Alto,  CA  94301
Applicant Contact NANCY LINCE
Correspondent
N.V. Kema
P.O. Box 9035
6800 Et Arnhem
Arnhem,  NL
Correspondent Contact P.N. RUYS
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/12/2003
Decision Date 09/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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