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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 K771203
FOIA Releasable 510(k) K771203
Device Name DISP. HYPODERMIC NEEDLE
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 Number880.5570
Classification Product Code
FMI  
Date Received07/05/1977
Decision Date 07/14/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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