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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 K872329
Device Name INFUSE-A-PORT ADDITIONAL SIZES
Applicant
Shiley Infusaid, Inc.
1400 Providence Hwy.
Norwood,  MA  02062
Applicant Contact NANCY C HALL
Correspondent
Shiley Infusaid, Inc.
1400 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact NANCY C HALL
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/17/1987
Decision Date 11/13/1987
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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