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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 K904983
Device Name MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY
Applicant
MEADOX SURGIMED, INC.
112 BAUER DR.
OAKLAND,  NJ  07436
Applicant Contact NANCY C KOFFMAN
Correspondent
MEADOX SURGIMED, INC.
112 BAUER DR.
OAKLAND,  NJ  07436
Correspondent Contact NANCY C KOFFMAN
Regulation Number876.5470
Classification Product Code
EZN  
Date Received11/02/1990
Decision Date 01/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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