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FDA 510(k) Application Details - K040621
Device Classification Name
Mesh, Surgical
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510(K) Number
K040621
Device Name
Mesh, Surgical
Applicant
ACELL, INC
5610 WISCONSIN AVE
#304
CHEVY CHASE, MD 20815 US
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Contact
PATSY J TRISLER
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
FTM
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More FDA Info for this Product Code
Date Received
03/09/2004
Decision Date
04/14/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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