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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 K000665
Device Name TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
Applicant
TFX MEDICAL, INC.
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
TFX MEDICAL, INC.
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/28/2000
Decision Date 05/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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