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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 K921576
Device Name STRATO LIFEPORT LARGE BORE INFUSION SET
Applicant
Starto Medical Corp.
123 Brimbal Ave.
Beverly,  MA  01915
Applicant Contact NANCY C HALL
Correspondent
Starto Medical Corp.
123 Brimbal Ave.
Beverly,  MA  01915
Correspondent Contact NANCY C HALL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/02/1992
Decision Date 09/21/1992
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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