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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K850967
Device Name STERILE CORMED MEDIPORT
Applicant
Cormed, Inc., Sub. C.R.Bard, Inc.
591 Mahar St.
Medina,  NY  14103
Applicant Contact ERIC P ANKERUD
Correspondent
Cormed, Inc., Sub. C.R.Bard, Inc.
591 Mahar St.
Medina,  NY  14103
Correspondent Contact ERIC P ANKERUD
Regulation Number880.5965
Classification Product Code
LJT  
Date Received03/08/1985
Decision Date 05/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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