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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K850488
Device Name STRATOFUSE SYRINGE PIGGYBACK PUMP 1030
Applicant
Strato Medical Corp.
123 Brimbal Ave. P.O.B.3148
Beverly,  MA  01915
Applicant Contact ROBERT L MILLER
Correspondent
Strato Medical Corp.
123 Brimbal Ave. P.O.B.3148
Beverly,  MA  01915
Correspondent Contact ROBERT L MILLER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/07/1985
Decision Date 03/21/1985
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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