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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 K863407
Device Name GRAF CORELLO, POWERED WHEELCHAIR
Applicant
Graf Products, Inc.
3000 First Florida Tower C/O
Walter Aye
Tampa,  FL  33602
Applicant Contact WALTER E AYE
Correspondent
Graf Products, Inc.
3000 First Florida Tower C/O
Walter Aye
Tampa,  FL  33602
Correspondent Contact WALTER E AYE
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/03/1986
Decision Date 09/23/1986
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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