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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K931578
Device Name TEXAS SCOTTISH RITE EASY/LOCK FIXATOR
Applicant
Applied Osteo Systems, Inc.
1243 Alpine Rd.
Suite 221
Walnut Creek,  CA  94596
Applicant Contact MICHAEL PENTOPOULOS
Correspondent
Applied Osteo Systems, Inc.
1243 Alpine Rd.
Suite 221
Walnut Creek,  CA  94596
Correspondent Contact MICHAEL PENTOPOULOS
Regulation Number888.3040
Classification Product Code
JEC  
Date Received03/30/1993
Decision Date 02/22/1994
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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