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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 K071846
Device Name MODIFICATION TO EZ HUBER SAFETY INFUSION SET
Applicant
PFM MEDICAL, INC
2605 TEMPLE HEIGHTS DRIVE
SUITE A
OCEANSIDE,  CA  92056
Applicant Contact SALVADORE PALOMARES
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/05/2007
Decision Date 08/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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