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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Administration Set Docking Station
510(k) Number K070163
Device Name SWABBABLE CAP, MODEL 60205
Applicant
Baxa Corp.
14445 Grasslands Dr.
Englewood,  CO  80112
Applicant Contact KIMBERLY ZIZIK
Correspondent
Baxa Corp.
14445 Grasslands Dr.
Englewood,  CO  80112
Correspondent Contact KIMBERLY ZIZIK
Regulation Number880.5440
Classification Product Code
ODI  
Date Received01/17/2007
Decision Date 08/03/2007
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
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