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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 K002142
Device Name SALINE IV FLUSH SYRINGE
Applicant
EMT-RX
9400 RANSDELL RD., SUITE 10
raleigh,  NC  27603
Applicant Contact robert j bard
Correspondent
EMT-RX
9400 RANSDELL RD., SUITE 10
raleigh,  NC  27603
Correspondent Contact robert j bard
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/17/2000
Decision Date 01/28/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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