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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 K193066
Device Name Steripack cases and Tray Systems
Applicant
Avalign Technologies, Inc.
8727 Clinton Park Dive
Fort Wayne,  IN  46825
Applicant Contact Hiren Patel
Correspondent
Avalign Technologies, Inc.
8727 Clinton Park Dive
Fort Wayne,  IN  46825
Correspondent Contact Heidi Funston
Regulation Number880.6850
Classification Product Code
KCT  
Date Received11/04/2019
Decision Date 08/06/2020
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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