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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 K870425
Device Name AUTO ENTRY SYSTEM (MATE)
Applicant
Kg Engineering, Inc.
115 Front St.
Woonsocket,  RI  02895
Applicant Contact HARRY A POLLOCK
Correspondent
Kg Engineering, Inc.
115 Front St.
Woonsocket,  RI  02895
Correspondent Contact HARRY A POLLOCK
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/03/1987
Decision Date 03/24/1987
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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