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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K252637
Device Name Community Containers (Flap and Daisy)
Applicant
Keter Canada, Inc.
205 Market Dr.
Milton,  CA L9T 4Z7
Applicant Contact Lovleen Kaur
Correspondent
The FDA Group
290 Turnpike Rd. Suite 200
Westborough,  MA  01581
Correspondent Contact Trey Thorsen
Regulation Number880.5570
Classification Product Code
MMK  
Date Received08/20/2025
Decision Date 10/14/2025
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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