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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 K925724
Device Name M100 POWERED WHEELCHAIR
Applicant
Mcnally Industries, Inc.
P.O. Box 129
216 Pine 129
Grantsburg,  WI  54840
Applicant Contact DON MORROW
Correspondent
Mcnally Industries, Inc.
P.O. Box 129
216 Pine 129
Grantsburg,  WI  54840
Correspondent Contact DON MORROW
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/13/1992
Decision Date 03/29/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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