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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanently Mounted Wheelchair Platform Lift
510(k) Number K122206
Device Name GARAVENTA X3 INCLINED PLATFORM LIFT
Applicant
Garaventa (Canada) Ltd [Dba Garaventa Lift]
845 Aronson Lake Ct.
Roswell,  GA  30075
Applicant Contact JAY MANSOUR
Correspondent
Garaventa (Canada) Ltd [Dba Garaventa Lift]
845 Aronson Lake Ct.
Roswell,  GA  30075
Correspondent Contact JAY MANSOUR
Regulation Number890.3930
Classification Product Code
PCE  
Date Received07/25/2012
Decision Date 03/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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