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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Accessories
510(k) Number K890867
Device Name TC SYSTEM-COVER
Applicant
Transmedical Corp.
2900 Lebanon Ave.
El Paso,  TX  79930
Applicant Contact ROBERTO QUINTANILLA
Correspondent
Transmedical Corp.
2900 Lebanon Ave.
El Paso,  TX  79930
Correspondent Contact ROBERTO QUINTANILLA
Regulation Number878.4580
Classification Product Code
FTA  
Date Received02/21/1989
Decision Date 03/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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