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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 S. State St.
Sandy,  UT  84070
Applicant Contact CLEARY
Correspondent
Warner-Lambert Co.
9450 S. 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
Predetermined Change
Control Plan Authorized
No
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