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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 K963227
Device Name WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175
Applicant
PRODUCTS FOR MEDICINE
52337 AVENIDA NAVARRO
LA QUINTA,  CA  92253
Applicant Contact D'ARCY DEEKS
Correspondent
PRODUCTS FOR MEDICINE
52337 AVENIDA NAVARRO
LA QUINTA,  CA  92253
Correspondent Contact D'ARCY DEEKS
Regulation Number876.1500
Classification Product Code
GCT  
Date Received08/19/1996
Decision Date 10/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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