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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K933431
Device Name ORTHOTRAC COAXIAL LASER
Applicant
Trac Medical, Inc.
4106 Wake Forest Rd.
Raliegh,  NC  27609
Applicant Contact TERRY N WILLIAMS
Correspondent
Trac Medical, Inc.
4106 Wake Forest Rd.
Raliegh,  NC  27609
Correspondent Contact TERRY N WILLIAMS
Regulation Number892.1650
Classification Product Code
OXO  
Date Received07/14/1993
Decision Date 10/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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