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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Loop, Wire
510(k) Number K870761
Device Name EAR LOOP
Applicant
TREACE MEDICAL, INC.
SUITE 400
22 NORTH SECOND STREET
MEMPHIS,  TN  38103
Applicant Contact THOMAS, JR
Correspondent
TREACE MEDICAL, INC.
SUITE 400
22 NORTH SECOND STREET
MEMPHIS,  TN  38103
Correspondent Contact THOMAS, JR
Regulation Number874.4420
Classification Product Code
JYQ  
Date Received02/26/1987
Decision Date 03/03/1987
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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