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FDA 510(k) Application Details - K032685
Device Classification Name
Cement Obturator
More FDA Info for this Device
510(K) Number
K032685
Device Name
Cement Obturator
Applicant
TEKNIMED SA
1001 OAKWOOD BLVD
ROUND ROCK, TX 78681 US
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Contact
J.D. WEBB
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
LZN
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More FDA Info for this Product Code
Date Received
08/29/2003
Decision Date
11/26/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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