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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 K051009
Device Name HUBER CLEAR SAFETY INFUSION SET
Applicant
Now Medical Distribution, Inc.
1205 De La Vina St.
Santa Barbara,  CA  93101
Applicant Contact CHRISTINE EMANNUEL
Correspondent
Now Medical Distribution, Inc.
1205 De La Vina St.
Santa Barbara,  CA  93101
Correspondent Contact CHRISTINE EMANNUEL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/21/2005
Decision Date 07/12/2005
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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