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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Catheter, Ureteral
510(k) Number K851463
Device Name OLBERT CATHETER SYS FOR URETERAL DILATION
Applicant
Meadox Surgimed, Inc.
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact JAMES HARTIGAN
Correspondent
Meadox Surgimed, Inc.
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact JAMES HARTIGAN
Regulation Number876.5470
Classification Product Code
EZN  
Date Received04/15/1985
Decision Date 05/23/1985
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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