FDA 510(k) Application Details - K960350

Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular

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510(K) Number K960350
Device Name Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant BIOCONTROL TECHNOLOGY, INC.
300 INDIAN SPRINGS RD.
P.O. BOX 434
INDIANA, PA 15701 US
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Contact PATRICK J COOPER
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Regulation Number 880.5965

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Classification Product Code LJT
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Date Received 01/25/1996
Decision Date 04/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K960350


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