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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K922952
Device Name SONGER CABLE SYSTEM
Applicant
Pioneer Surgical Technology
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact MATTHEW N SONGER
Correspondent
Pioneer Surgical Technology
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact MATTHEW N SONGER
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received06/18/1992
Decision Date 02/23/1993
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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