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FDA 510(k) Application Details - K992616
Device Classification Name
Cerclage, Fixation
More FDA Info for this Device
510(K) Number
K992616
Device Name
Cerclage, Fixation
Applicant
PIONEER SURGICAL TECHNOLOGY
375 RIVER PARK CIRCLE
MARQUETTE, MI 49855-0627 US
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Contact
BURNS SEVERSON
Other 510(k) Applications for this Contact
Regulation Number
888.3010
More FDA Info for this Regulation Number
Classification Product Code
JDQ
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More FDA Info for this Product Code
Date Received
08/04/1999
Decision Date
10/27/1999
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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