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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 K980281
Device Name WELCH ALLYN XENON 300 LIGHT SOURCE
Applicant
Welch Allyn, Inc.
4619 Jordan Rd.
Skaneateles Falls,  NY  13153
Applicant Contact KATHY LOWTHER
Correspondent
Welch Allyn, Inc.
4619 Jordan Rd.
Skaneateles Falls,  NY  13153
Correspondent Contact KATHY LOWTHER
Regulation Number876.1500
Classification Product Code
GCT  
Subsequent Product Code
FCW  
Date Received01/26/1998
Decision Date 02/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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