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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name attachment, eyepiece, for insertion of prescription lens
510(k) Number K852642
Device Name CENTRAL VEIN CATHETERIZATION TRAY
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 Number876.1500
Classification Product Code
FDZ  
Date Received06/21/1985
Decision Date 01/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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