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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 K992050
Device Name LUMENON XENON LIGHT SOURCE
Applicant
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218 -2480
Applicant Contact TREVOR BYRD
Correspondent
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218 -2480
Correspondent Contact TREVOR BYRD
Regulation Number876.1500
Classification Product Code
GCT  
Date Received06/17/1999
Decision Date 09/14/1999
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
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