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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Medical Examination, Ac Powered
510(k) Number K934259
Device Name AC-POWERED MEDICAL EXAMINATION LIGHT
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Applicant Contact KATHY H MASTRIANI
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Correspondent Contact KATHY H MASTRIANI
Regulation Number880.6320
Classification Product Code
KZF  
Date Received08/31/1993
Decision Date 01/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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