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FDA 510(k) Application Details - K023778
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K023778
Device Name
Dressing, Wound, Collagen
Applicant
TEI BIOSCIENCES INC.
7 ELKINS ST.
BOSTON, MA 02127 US
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Contact
KENNETH JAMES
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
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More FDA Info for this Product Code
Date Received
11/12/2002
Decision Date
09/29/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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