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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 K970311
Device Name BENTLEY MANUALLY OPERATED WHEELCHAIR
Applicant
Pdg Product Design Group, Inc.
9165 Shaughnessy St.
Vancouver, Bc,  CA V6P 6R9
Applicant Contact PHIL MUNDY
Correspondent
Pdg Product Design Group, Inc.
9165 Shaughnessy St.
Vancouver, Bc,  CA V6P 6R9
Correspondent Contact PHIL MUNDY
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/27/1997
Decision Date 02/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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