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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal Dialysis, Single Use
510(k) Number K885037
Device Name AMUKIN 50% - AIRSPRAY(R)
Applicant
Bernard J. Cooney, P.A.
2 Wisconsin Cir.
Suite 706
Chevy Chase,  MD  20815
Applicant Contact JOANNE OGILVIE
Correspondent
Bernard J. Cooney, P.A.
2 Wisconsin Cir.
Suite 706
Chevy Chase,  MD  20815
Correspondent Contact JOANNE OGILVIE
Regulation Number876.5630
Classification Product Code
FKO  
Date Received12/05/1988
Decision Date 10/19/1990
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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