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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K922095
Device Name LX 150 LIGHT SOURCE
Applicant
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153 -0220
Applicant Contact LAWRENCE E MAROCCO
Correspondent
Welch Allyn, Inc.
4341 State St. Rd.
P.O. Box 220
Skaneateles Falls,  NY  13153 -0220
Correspondent Contact LAWRENCE E MAROCCO
Regulation Number874.4350
Classification Product Code
EQH  
Date Received05/05/1992
Decision Date 07/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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