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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 K011687
Device Name MP-3C POWER BASE CHAIR, MODEL MP3C
Applicant
MERITS HEALTH PRODUCTS., INC.
P.O. BOX 150356
CAPE CORAL,  FL  33915
Applicant Contact WINSTON ANDERSON
Correspondent
MERITS HEALTH PRODUCTS., INC.
P.O. BOX 150356
CAPE CORAL,  FL  33915
Correspondent Contact WINSTON ANDERSON
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/31/2001
Decision Date 08/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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