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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Fiberoptic, Routine
510(k) Number K032430
Device Name ACUEITY MEDICAL LIGHT SOURCE
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 Number876.1500
Classification Product Code
FCW  
Date Received08/06/2003
Decision Date 09/05/2003
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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