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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K981591
Device Name VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
Applicant
International Regulatory Consultants
2471 E. Shadow Wood Cir.
P.O. Box 17801
Salt Lake City,  UT  84117
Applicant Contact DONALD F GRABARZ
Correspondent
International Regulatory Consultants
2471 E. Shadow Wood Cir.
P.O. Box 17801
Salt Lake City,  UT  84117
Correspondent Contact DONALD F GRABARZ
Regulation Number876.4620
Classification Product Code
FAD  
Date Received05/04/1998
Decision Date 10/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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