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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K924851
Device Name STRATO MEDICAL SINGLE LUMEN VALVED CATHETER
Applicant
Strato Medical Corp.
123 Brimbal Ave. P.O.B.3148
Beverly,  MA  01915
Applicant Contact FREDERICK J MARANO
Correspondent
Strato Medical Corp.
123 Brimbal Ave. P.O.B.3148
Beverly,  MA  01915
Correspondent Contact FREDERICK J MARANO
Regulation Number880.5970
Classification Product Code
LJS  
Date Received09/28/1992
Decision Date 12/13/1993
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
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