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510(k) K933431

ORTHOTRAC COAXIAL LASER by Trac Medical, Inc. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1993
Date Received
July 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image-Intensified Fluoroscopic X-Ray System, Mobile
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Fluoroscopy of the human body.

Other clearances by Trac Medical, Inc.

  • K944345 — BEDSIDE BUTLER (October 17, 1994)

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