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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 K001709
Device Name TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
Applicant
PIONEER SURGICAL TECHNOLOGY
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Applicant Contact AMY H MOMMAERTS
Correspondent
PIONEER SURGICAL TECHNOLOGY
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Correspondent Contact AMY H MOMMAERTS
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received06/05/2000
Decision Date 08/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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