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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K862755
Device Name DUNN ANTERIOR DISTRACTION SYSTEM
Applicant
Osteotek, Inc.
559 E. S. Temple St.
Salt Lake City,  UT  84102
Applicant Contact REID RUSSELL
Correspondent
Osteotek, Inc.
559 E. S. Temple St.
Salt Lake City,  UT  84102
Correspondent Contact REID RUSSELL
Date Received07/22/1986
Decision Date 01/22/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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