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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K862107
Device Name PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR
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 Number876.1500
Classification Product Code
ODC  
Date Received06/03/1986
Decision Date 09/11/1986
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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