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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 K882157
Device Name PANAMEX(TM) URETERAL STENT
Applicant
Kingston Technologies, Inc.
2235 Rte. 130
Dayton,  NJ  08810
Applicant Contact MARC JACOBS
Correspondent
Kingston Technologies, Inc.
2235 Rte. 130
Dayton,  NJ  08810
Correspondent Contact MARC JACOBS
Regulation Number876.4620
Classification Product Code
FAD  
Date Received05/23/1988
Decision Date 08/02/1988
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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