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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K920403
Device Name XENON ARC ENDOSCOPE LIGHT SOURCE
Applicant
MEDICAL DEVICE INSPECTION CO., INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
MEDICAL DEVICE INSPECTION CO., INC.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/31/1992
Decision Date 02/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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