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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 K911782
Device Name PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM
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 Number880.5725
Classification Product Code
FRN  
Date Received04/22/1991
Decision Date 11/22/1991
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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