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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 K905845
Device Name STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED
Applicant
Strato Medical Corp.
123 Brimbal Ave. P.O.B.3148
Beverly,  MA  01915
Applicant Contact NANCY C HALL
Correspondent
Strato Medical Corp.
123 Brimbal Ave. P.O.B.3148
Beverly,  MA  01915
Correspondent Contact NANCY C HALL
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/27/1990
Decision Date 04/19/1991
Decision Substantially Equivalent - Kit (SESK)
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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