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510(k) K890867

TC SYSTEM-COVER by Transmedical Corp. — Product Code FTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1989
Date Received
February 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Accessories
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Transmedical Corp.

  • K890866 — TC SYSTEM-HANDLE (March 14, 1989)

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  • K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX (August 11, 2005)
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