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FDA 510(k) Application Details - K053637
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyamide
More FDA Info for this Device
510(K) Number
K053637
Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Applicant
MANI, INC.
1301K STREET, N.W.
SUITE 1100 - EAST TOWER
WASHINGTON, DC 20005-3373 US
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Contact
DAVID J BLOCH
Other 510(k) Applications for this Contact
Regulation Number
878.5020
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Classification Product Code
GAR
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More FDA Info for this Product Code
Date Received
12/29/2005
Decision Date
05/19/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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