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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name port & catheter, implanted, subcutaneous, intravascular
510(k) Number K122402
Device Name LPP (LOW PROFILE PORT)
Original Applicant
PFM MEDICAL, INC
1815 aston ave, suite 106
carlsbad,  CA  92008
Original Contact salvadore palomares, rac
Regulation Number880.5965
Classification Product Code
LJT  
Date Received08/07/2012
Decision Date 07/16/2013
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
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