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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 K951647
Device Name WELCH ALLYN HI - LUX ILLUMINATOR
Applicant
WELCH ALLYN, INC.
4619 JORDAN RD.
P.O. BOX 187
SKANEATELES FALLS,  NY  13153 -0187
Applicant Contact MARY K TESORO
Correspondent
WELCH ALLYN, INC.
4619 JORDAN RD.
P.O. BOX 187
SKANEATELES FALLS,  NY  13153 -0187
Correspondent Contact MARY K TESORO
Regulation Number876.1500
Classification Product Code
FCW  
Date Received04/10/1995
Decision Date 05/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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