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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 K993160
Device Name OMEGA TRAC, MODEL Z100
Applicant
Teftec Corp.
6929 Old Spring Branch Rd.
Spring Branch,  TX  78070
Applicant Contact THOMAS E FINCH, III
Correspondent
Teftec Corp.
6929 Old Spring Branch Rd.
Spring Branch,  TX  78070
Correspondent Contact THOMAS E FINCH, III
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/21/1999
Decision Date 11/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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