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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 K060582
Device Name INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR
Applicant
INVACARE CORPORATION
ONE INVACARE WAY
ELYRIA,  OH  44035 -4190
Applicant Contact CARROLL MARTIN
Correspondent
INVACARE CORPORATION
ONE INVACARE WAY
ELYRIA,  OH  44035 -4190
Correspondent Contact CARROLL MARTIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/07/2006
Decision Date 03/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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