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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image, Illumination, Fiberoptic, For Endoscope
510(k) Number K061025
Device Name ACCUTECH ENDOLITE PROBE
Applicant
Accutech Medical Technologies, Inc.
3637 Bernal Ave.
Pleasanton,  CA  94566
Applicant Contact ANNE WORDEN
Correspondent
Accutech Medical Technologies, Inc.
3637 Bernal Ave.
Pleasanton,  CA  94566
Correspondent Contact ANNE WORDEN
Regulation Number876.1500
Classification Product Code
FFS  
Date Received04/13/2006
Decision Date 05/31/2006
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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