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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K885202
Device Name 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR
Applicant
COEUR LABORATORIES, INC.
5301 DEPATURE DR.
RALEIGH,  NC  27604
Applicant Contact TERESA R MCCLEERY
Correspondent
COEUR LABORATORIES, INC.
5301 DEPATURE DR.
RALEIGH,  NC  27604
Correspondent Contact TERESA R MCCLEERY
Regulation Number876.5130
Classification Product Code
KOD  
Date Received12/16/1988
Decision Date 01/31/1989
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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