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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Explorer, Operative
510(k) Number K823914
Device Name EXPLORER TIP
Applicant
Treace Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Treace Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.4565
Classification Product Code
EKB  
Date Received12/28/1982
Decision Date 01/21/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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