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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K951627
Device Name INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM
Applicant
Infinitech, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Applicant Contact ALAN T BECKMAN
Correspondent
Infinitech, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Correspondent Contact ALAN T BECKMAN
Regulation Number876.1500
Classification Product Code
MPA  
Date Received04/07/1995
Decision Date 10/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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