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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 K960350
Device Name THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602
Applicant
BIOCONTROL TECHNOLOGY, INC.
300 INDIAN SPRINGS RD.
P.O. BOX 434
INDIANA,  PA  15701
Applicant Contact PATRICK J COOPER
Correspondent
BIOCONTROL TECHNOLOGY, INC.
300 INDIAN SPRINGS RD.
P.O. BOX 434
INDIANA,  PA  15701
Correspondent Contact PATRICK J COOPER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received01/25/1996
Decision Date 04/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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