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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, long-term greater than 30 days
510(k) Number K083873
Device Name PICC (CT RATED AND NON-RATED)
Applicant
PFM MEDICAL, INC
2605 TEMPLE HEIGHTS DRIVE
SUITE A
OCEANSIDE,  CA  92056
Applicant Contact SALVADORE PALOMARES
Correspondent
PFM MEDICAL, INC
2605 TEMPLE HEIGHTS DRIVE
SUITE A
OCEANSIDE,  CA  92056
Correspondent Contact SALVADORE PALOMARES
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/29/2008
Decision Date 03/19/2009
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
Recalls CDRH Recalls
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