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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, Endoscope, Xenon Arc
510(k) Number K951971
Device Name XENON LIGHT SOURCE
Applicant
Envision Medical Corp.
749 Ward Dr.
Santa Barbara,  CA  93111
Applicant Contact DANIEL P MCGUIRE
Correspondent
Envision Medical Corp.
749 Ward Dr.
Santa Barbara,  CA  93111
Correspondent Contact DANIEL P MCGUIRE
Regulation Number876.1500
Classification Product Code
GCT  
Date Received04/27/1995
Decision Date 05/24/1995
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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