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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, disposable
510(k) Number K760775
Device Name TERUMO DISPOSABLE SPINAL 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 Number878.4800
Classification Product Code
GAA  
Date Received10/04/1976
Decision Date 11/01/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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