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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K870582
Device Name LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE
Applicant
STRATO MEDICAL CORP.
123 BRIMBAL AVE. P.O.B.3148
BEVERLY,  MA  01915
Applicant Contact FENTON, JR.
Correspondent
STRATO MEDICAL CORP.
123 BRIMBAL AVE. P.O.B.3148
BEVERLY,  MA  01915
Correspondent Contact FENTON, JR.
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/11/1987
Decision Date 04/23/1987
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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