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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Manual Surgical Instrument
510(k) Number K944188
Device Name SPINAL MARKER
Applicant
Leibinger L.P.
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Applicant Contact ANDREW B ROGERS
Correspondent
Leibinger L.P.
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Correspondent Contact ANDREW B ROGERS
Regulation Number888.4540
Classification Product Code
LXH  
Date Received08/26/1994
Decision Date 04/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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