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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 K213209
Device Name EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device
Applicant
K1 Medical, LLC
56 Newton Rd.
Woodbridge,  CT  06525
Applicant Contact Walt Oko
Correspondent
Joseph Azary
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact Joseph Azary
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/29/2021
Decision Date 12/28/2021
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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