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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Ear Suction
510(k) Number K841357
Device Name MICRO FLUID APPLICATOR
Applicant
TREACE MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TREACE MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4420
Classification Product Code
JZF  
Date Received04/02/1984
Decision Date 08/24/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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