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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K870757
Device Name OTOLOGICAL METRIC SCALE/GAUGE
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
Date Received02/26/1987
Decision Date 03/06/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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