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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 K905282
Device Name ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE
Applicant
Frantz Medical Development, Ltd.
595 Madison Ave.
New York,  NY  10022
Applicant Contact MAUREEN D RODEN
Correspondent
Frantz Medical Development, Ltd.
595 Madison Ave.
New York,  NY  10022
Correspondent Contact MAUREEN D RODEN
Regulation Number876.1500
Classification Product Code
GCT  
Date Received11/23/1990
Decision Date 03/19/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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