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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, short-term less than 30 days
510(k) Number K032417
Device Name HEPARIN LOCK FLUSH SYRINGE
Applicant
AM2 PAT INC.
9400 RANSDELL RD., SUITE 10
RALEIGH,  NC  27603
Applicant Contact DUSHYANT PATEL
Correspondent
AM2 PAT INC.
9400 RANSDELL RD., SUITE 10
RALEIGH,  NC  27603
Correspondent Contact DUSHYANT PATEL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/05/2003
Decision Date 12/23/2003
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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