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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Disinfectant, Medical Devices
510(k) Number K870759
Device Name CLEANING SOLUTION, CATALOG NO. 8203
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 Number880.6890
Classification Product Code
LRJ  
Date Received02/26/1987
Decision Date 05/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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