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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Catheter, Fiberoptic, Glass, Ureteral
510(k) Number K943801
Device Name URIGLOW TRANSILLUMINATING URETERIC STENT MODEL
Applicant
Rocket of London, Ltd.
Wear Industrial Estate
Washington
Tyne & Wear,  GB NE37 1NE
Applicant Contact RICHARD KEEN
Correspondent
Rocket of London, Ltd.
Wear Industrial Estate
Washington
Tyne & Wear,  GB NE37 1NE
Correspondent Contact RICHARD KEEN
Regulation Number876.4020
Classification Product Code
FCS  
Date Received08/03/1994
Decision Date 08/15/1995
Decision Substantially Equivalent (SESE)
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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