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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 K924897
Device Name XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
Applicant
MEDICAL DEVICES, INC.
83 HOBART ST.
HACKENSACK,  NJ  07601
Applicant Contact SAMUEL DICKSTEIN
Correspondent
MEDICAL DEVICES, INC.
83 HOBART ST.
HACKENSACK,  NJ  07601
Correspondent Contact SAMUEL DICKSTEIN
Regulation Number876.1500
Classification Product Code
GCT  
Date Received09/29/1992
Decision Date 07/06/1993
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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