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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Catheter
510(k) Number K863446
Device Name ANGIOMED HIGH PRESSURE CONNECTORS
Applicant
ANGIOMED U.S., INC.
4081 EAST LA PALMA AVE.,
SUITE E
ANAHEIM,  CA  92807
Applicant Contact RICHARD P MOHR
Correspondent
ANGIOMED U.S., INC.
4081 EAST LA PALMA AVE.,
SUITE E
ANAHEIM,  CA  92807
Correspondent Contact RICHARD P MOHR
Regulation Number878.4200
Classification Product Code
GCD  
Date Received09/08/1986
Decision Date 09/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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