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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, headband, surgical
510(k) Number K031548
Device Name LED HEADLIGHT
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Applicant Contact DAVID KLEMENTOWSKI
Correspondent
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Correspondent Contact DAVID KLEMENTOWSKI
Regulation Number886.4335
Classification Product Code
FSR  
Date Received05/16/2003
Decision Date 08/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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