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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name splint, nasal
510(k) Number K863382
Device Name CANNON NASAL SPLINT
Applicant
TREACE MEDICAL, INC.
SUITE 400
22 NORTH SECOND STREET
MEMPHIS,  TN  38103
Applicant Contact WILLIAM H THOMAS,JR
Correspondent
TREACE MEDICAL, INC.
SUITE 400
22 NORTH SECOND STREET
MEMPHIS,  TN  38103
Correspondent Contact WILLIAM H THOMAS,JR
Regulation Number874.5800
Classification Product Code
EPP  
Date Received09/03/1986
Decision Date 10/07/1986
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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