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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 K031994
Device Name LINVATEC 300W XENON LIGHT SOURCE
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact LAURA D KREJCI
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact LAURA D KREJCI
Regulation Number876.1500
Classification Product Code
GCT  
Date Received06/27/2003
Decision Date 08/21/2003
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
Recalls CDRH Recalls
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