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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 K031549
Device Name SOLID STATE LAMP [LED] HEADLIGHT
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Applicant Contact DAVID KLEMENTOWSKI
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
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
Predetermined Change
Control Plan Authorized		 No
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