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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K831588
Device Name INSTRUMENT GUARD CAPSULE
Applicant
Treace Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Treace Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6850
Classification Product Code
KCT  
Date Received05/17/1983
Decision Date 06/15/1983
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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