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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, i.v. fluid transfer
510(k) Number K090917
Device Name SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
Applicant
BAXA CORP.
14445 GRASSLANDS DR.
ENGLEWOOD,  CO  80112 -7062
Applicant Contact JIM MORGAN
Correspondent
BAXA CORP.
14445 GRASSLANDS DR.
ENGLEWOOD,  CO  80112 -7062
Correspondent Contact JIM MORGAN
Regulation Number880.5440
Classification Product Code
LHI  
Date Received04/01/2009
Decision Date 02/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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