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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 K801557
Device Name ROLLS ROLLITE WHEELCHAIR
Applicant
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA,  OH  44036
Correspondent
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA,  OH  44036
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/08/1980
Decision Date 07/21/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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