FDA 510(k) Application Details - K961267

Device Classification Name Cerclage, Fixation

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510(K) Number K961267
Device Name Cerclage, Fixation
Applicant PIONEER SURGICAL TECHNOLOGY
375 RIVER PARK CIRCLE
MARQUETTE, MI 49855 US
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Contact BURNS SEVERSON
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Regulation Number 888.3010

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Classification Product Code JDQ
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Date Received 04/02/1996
Decision Date 06/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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