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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 K211007
Device Name EZ-TRAXTM Persona Knee Containment Device
Applicant
K1 Medical, LLC
56 Newton Rd.
Woodbridge,  CT  06525
Applicant Contact Walt Oko
Correspondent
K1 Medical, LLC
56 Newton Rd.
Woodbridge,  CT  06525
Correspondent Contact Walt Oko
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/02/2021
Decision Date 07/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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