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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Blood Level
510(k) Number K952691
Device Name WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Applicant Contact MARY KAY TESORO
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153
Correspondent Contact MARY KAY TESORO
Regulation Number876.5820
Classification Product Code
FJC  
Date Received06/12/1995
Decision Date 07/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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