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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K163432
Device Name Stellar LEAP
Applicant
Pdg Product Design Group, Inc.
103 - 318 E. Kent Ave. S.
Vancouver,  CA V5X4NC
Applicant Contact Torr Brown
Correspondent
Canopy Medical, LLC
1160 Vierling Dr.
Shakopee,  MN  55379
Correspondent Contact Georgiann Keyport
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/07/2016
Decision Date 06/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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