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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 K001777
Device Name MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
Applicant
INVACARE CORP.
ONE INVACARE WAY
ELYRIA,  OH  44036 -2125
Applicant Contact EDWARD A KROLL
Correspondent
INVACARE CORP.
ONE INVACARE WAY
ELYRIA,  OH  44036 -2125
Correspondent Contact EDWARD A KROLL
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/13/2000
Decision Date 07/24/2000
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
Recalls CDRH Recalls
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