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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 K993032
Device Name MODIFICATION TO MP-3 POWER BASE CHAIR
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 Received08/10/1999
Decision Date 11/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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