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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K960698
Device Name NON-CORING NEEDLE
Applicant
MED INSTITUTE, INC.
P.O. BOX 2402
WEST LAFAYETTE,  IN  47906
Applicant Contact NEAL E FEARNOT, PH.D., E.E.
Correspondent
MED INSTITUTE, INC.
P.O. BOX 2402
WEST LAFAYETTE,  IN  47906
Correspondent Contact NEAL E FEARNOT, PH.D., E.E.
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/20/1996
Decision Date 04/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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