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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 K895871
Device Name LIFEPORT POLYURETHANE CATHETER
Applicant
Strato Medical Corp.
123 Brimbal Ave. P.O.B.3148
Beverly,  MA  01915
Applicant Contact JOSEPH RESS
Correspondent
Strato Medical Corp.
123 Brimbal Ave. P.O.B.3148
Beverly,  MA  01915
Correspondent Contact JOSEPH RESS
Regulation Number880.5965
Classification Product Code
LJT  
Date Received10/04/1989
Decision Date 11/17/1989
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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