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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
Jeffrey,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
Tfx Medical, Inc.
Tall Pines Park
Jeffrey,  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
Predetermined Change
Control Plan Authorized		 No
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