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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 K061475
Device Name ASTROTILT MANUAL WHEELCHAIR
Applicant
PDG PRODUCT DESIGN GROUP, INC.
UNIT 102-366 E. KENT AVE.
SOUTH
VANCOUVER, BC,  CA V5X 4N6
Applicant Contact NANCY BALCOM
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MARC MOUSER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/30/2006
Decision Date 06/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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