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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 K910750
Device Name FORTRESS CUSTOM MANUAL FOLDING WHEELCHAIR
Applicant
Fortress Litestyle
1775 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact KNABLE GOTTS
Correspondent
Fortress Litestyle
1775 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact KNABLE GOTTS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/21/1991
Decision Date 03/05/1991
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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