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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Ent
510(k) Number K870758
Device Name SMALL MASTOID RETRACTOR
Applicant
Treace Medical, Inc.
Suite 400
22 N. Second St.
Memphis,  TN  38103
Applicant Contact THOMAS, JR
Correspondent
Treace Medical, Inc.
Suite 400
22 N. Second St.
Memphis,  TN  38103
Correspondent Contact THOMAS, JR
Regulation Number874.4420
Classification Product Code
KAL  
Date Received02/26/1987
Decision Date 03/04/1987
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
Predetermined Change
Control Plan Authorized		 No
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