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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 K851142
Device Name TELET-LEX MEDICAL IV CATHETER PLACEMENT
Applicant
Teleflex Medical, Inc.
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact HERBERT M CARTER
Correspondent
Teleflex Medical, Inc.
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact HERBERT M CARTER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/21/1985
Decision Date 07/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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