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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K931546
Device Name END-IRRIGATING ENDOILLUMINATOR
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 Number878.4580
Classification Product Code
FST  
Date Received03/29/1993
Decision Date 02/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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