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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 K955819
Device Name A2 DETACHED DUAL PORT SYSTEM
Applicant
ARROW INTL., INC.
1600 PROVIDENCE HIGHWAY
WALPOLE,  MA  02081
Applicant Contact RICHARD J CLARK
Correspondent
ARROW INTL., INC.
1600 PROVIDENCE HIGHWAY
WALPOLE,  MA  02081
Correspondent Contact RICHARD J CLARK
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/26/1995
Decision Date 03/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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