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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 K162696
Device Name Kuschall Advance Manual Wheelchair
Applicant
INVACARE CORPORATION
ONE INVACARE WAY
ELYRIA,  OH  44035
Applicant Contact ELIJAH N. WREH
Correspondent
INVACARE CORPORATION
ONE INVACARE WAY
ELYRIA,  OH  44035
Correspondent Contact ELIJAH N. WREH
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/27/2016
Decision Date 12/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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