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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headlamp, Operating, Ac-Powered
510(k) Number K952289
Device Name WELCH ALLYN FIBER OPTIC HEADLIGNT
Applicant
Welch Allyn, Inc.
4341 S. State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Applicant Contact MARY KAY TESORO
Correspondent
Welch Allyn, Inc.
4341 S. State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Correspondent Contact MARY KAY TESORO
Regulation Number886.4335
Classification Product Code
HPQ  
Date Received05/16/1995
Decision Date 07/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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