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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 K861510
Device Name MULTILUMEN VIAPIC CENTRAL LINE CATHETER
Applicant
WARNER-LAMBERT CO.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Applicant Contact CLEARY
Correspondent
WARNER-LAMBERT CO.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Correspondent Contact CLEARY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/23/1986
Decision Date 06/09/1986
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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