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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Endoscope, Xenon Arc
510(k) Number K940270
Device Name LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
Applicant
Welch Allyn, Inc.
4619 Jordan Rd.
Skaneateles Falls,  NY  13153
Applicant Contact DAVID KLEMENTOWSKI
Correspondent
Welch Allyn, Inc.
4619 Jordan Rd.
Skaneateles Falls,  NY  13153
Correspondent Contact DAVID KLEMENTOWSKI
Regulation Number876.1500
Classification Product Code
GCT  
Date Received01/21/1994
Decision Date 04/20/1994
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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