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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K970855
FOIA Releasable 510(k) K970855
Device Name CLAVE CONNECTOR
Applicant
Icu Medical, Inc.
951 Calle Amanecer
San Clemente,  CA  92673
Applicant Contact ARLENE DUTCHIK
Correspondent
Icu Medical, Inc.
951 Calle Amanecer
San Clemente,  CA  92673
Correspondent Contact ARLENE DUTCHIK
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/10/1997
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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