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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K992932
Device Name CIPA (ADULTS) CIPI (INFANTS)
Applicant
DMC MEDICAL LTD.
511 CATALINA RD.
FULLERTON,  CA  92835
Applicant Contact CHARMAINE HENDERSON
Correspondent
DMC MEDICAL LTD.
511 CATALINA RD.
FULLERTON,  CA  92835
Correspondent Contact CHARMAINE HENDERSON
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/31/1999
Decision Date 06/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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