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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 K992627
Device Name FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500
Applicant
Teftec Corp.
6929 Old Spring Branch Rd.
Spring Branch,  TX  78070
Applicant Contact THOMAS E FINCH
Correspondent
Teftec Corp.
6929 Old Spring Branch Rd.
Spring Branch,  TX  78070
Correspondent Contact THOMAS E FINCH
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/05/1999
Decision Date 10/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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