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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 K173391
Device Name OsteoMed QuickFix Hybrid MMF Sterilization Tray
Applicant
Osteomed, LLC
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact Jessica M. Ruperto
Correspondent
Osteomed, LLC
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact Kathryn A. Jayne
Regulation Number880.6850
Classification Product Code
KCT  
Date Received10/30/2017
Decision Date 05/10/2018
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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