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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 K953073
Device Name LOW PROFILE TITANIUM MODEL CATALOG #1003
Original Applicant
ARROW INTL., INC.
1600 providence highway
walpole,  MA  02081
Original Contact bradley j enegren
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/30/1995
Decision Date 09/19/1995
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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