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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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