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510(k) K083710

RETRACTOR LITE by Thomas Surgical Instruments, Inc. — Product Code FST

K083710 is an FDA 510(k) premarket notification submitted by Thomas Surgical Instruments, Inc. for the device "RETRACTOR LITE". The FDA issued a decision of Substantially Equivalent on February 23, 2009. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2009
Date Received
December 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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FDA data resources