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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K002157
Device Name RANGER II M6, MODEL IN-888WNL
Applicant
Invacare Corp.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Invacare Corp.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/17/2000
Decision Date 08/25/2000
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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