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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stand, Infusion
510(k) Number K770422
Device Name CATHETER, SURFLO, I.V.
Applicant
Terumo America, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Terumo America, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6990
Classification Product Code
FOX  
Date Received03/07/1977
Decision Date 03/16/1977
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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