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FDA 510(k) Application Details - K051190
Device Classification Name
More FDA Info for this Device
510(K) Number
K051190
Device Name
XENFORM SOFT TISSUE REPAIR MATRIX
Applicant
TEI BIOSCIENCES INC.
7 ELKINS ST.
BOSTON, MA 02127 US
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Contact
KENNETH JAMES
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Regulation Number
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Classification Product Code
PAJ
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Date Received
05/10/2005
Decision Date
06/10/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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