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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Positioning, Electric
510(k) Number K073565
Device Name STANDARD WHEELCHAIR PLATFORM
Applicant
DESIGN SPECIFIC LTD
1310 TEMPLAR BLVD.
NORFOLK,  VA  23518
Applicant Contact DAWN EDWARDS
Correspondent
DESIGN SPECIFIC LTD
1310 TEMPLAR BLVD.
NORFOLK,  VA  23518
Correspondent Contact DAWN EDWARDS
Regulation Number890.3110
Classification Product Code
INO  
Date Received12/19/2007
Decision Date 02/06/2009
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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