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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 K880360
Device Name MODEL #1551 SWITCH CONTROL INTERFACE UNIT
Applicant
INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA,  OH  44036
Applicant Contact JAMES R THALER
Correspondent
INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA,  OH  44036
Correspondent Contact JAMES R THALER
Regulation Number890.3860
Classification Product Code
ITI  
Date Received01/26/1988
Decision Date 09/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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