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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 K901949
Device Name IV SET
Applicant
Jfv, Inc.
P.O. Box 348
33 S. Main St.
Spencer,  IN  47460
Applicant Contact VANCE, SR.
Correspondent
Jfv, Inc.
P.O. Box 348
33 S. Main St.
Spencer,  IN  47460
Correspondent Contact VANCE, SR.
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/30/1990
Decision Date 09/12/1990
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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