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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, Fiberoptic, Routine
510(k) Number K993300
Device Name COLDLIGHTSOURCE PL3000
Applicant
FIBER IMAGING TECHNOLOGIES, INC.
45 PONTIAC RD.
NEWTON,  MA  02468
Applicant Contact JOSEPH RESS
Correspondent
FIBER IMAGING TECHNOLOGIES, INC.
45 PONTIAC RD.
NEWTON,  MA  02468
Correspondent Contact JOSEPH RESS
Regulation Number876.1500
Classification Product Code
FCW  
Date Received10/01/1999
Decision Date 11/05/1999
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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