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FDA 510(k) Application Details - K053636
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
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510(K) Number
K053636
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
MANI, INC.
1301K STREET, N.W.
SUITE 1100 - EAST TOWER
WASHINGTON, DC 20005-3373 US
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Contact
DAVID J BLOCH
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Regulation Number
878.4493
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Classification Product Code
GAM
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More FDA Info for this Product Code
Date Received
12/29/2005
Decision Date
03/14/2006
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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