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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 K953529
Device Name STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
Applicant
Strato/Infusaid, Inc.
1400 Providence Hwy.
Norwood,  MA  02062
Applicant Contact CRAIG M AUDET
Correspondent
Strato/Infusaid, Inc.
1400 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact CRAIG M AUDET
Regulation Number880.5965
Classification Product Code
LJT  
Date Received07/27/1995
Decision Date 01/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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