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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K240862
Device Name Medicom Sterilization Wrap
Applicant
Medicom Group, Inc.
2555 Chemin De L’Aviation
Pointe-Claire,  CA H9P 2Z2
Applicant Contact Brent Geiger
Correspondent
Medicom Group, Inc.
2555 Chemin De L’Aviation
Pointe-Claire,  CA H9P 2Z2
Correspondent Contact Brent Geiger
Regulation Number880.6850
Classification Product Code
FRG  
Date Received03/28/2024
Decision Date 06/21/2024
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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