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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 K243589
Device Name PAL Sterilization Case
Applicant
Microaire Surgical Instruments, LLC
3590 Grand Forks Blvd.
Charlottesville,  VA  22911
Applicant Contact Glenn Gerstenfeld
Correspondent
Microaire Surgical Instruments, LLC
3590 Grand Forks Blvd.
Charlottesville,  VA  22911
Correspondent Contact Ashley Sanguinetti
Regulation Number880.6850
Classification Product Code
KCT  
Date Received11/20/2024
Decision Date 06/20/2025
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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