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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Basket, Ureteral, Metal
510(k) Number K862729
Device Name PENN 3-RING HANDLE
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 Number876.4680
Classification Product Code
FFL  
Date Received07/18/1986
Decision Date 10/24/1986
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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