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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 K871667
Device Name URETERAL STENT
Applicant
Penn Medical Devices, Inc.
12 Ridge St.
Basking Ridge,  NJ  07920
Applicant Contact ANN SALTARELLI
Correspondent
Penn Medical Devices, Inc.
12 Ridge St.
Basking Ridge,  NJ  07920
Correspondent Contact ANN SALTARELLI
Regulation Number876.4620
Classification Product Code
FAD  
Date Received04/28/1987
Decision Date 06/10/1987
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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