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FDA 510(k) Application Details - K123811
Device Classification Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
More FDA Info for this Device
510(K) Number
K123811
Device Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Applicant
ORIGAMI SURGICAL LLC
79 HAVEN ST.
DOVER, MA 02030 US
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Contact
JOHN GILLESPIE
Other 510(k) Applications for this Contact
Regulation Number
878.5035
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Classification Product Code
NBY
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More FDA Info for this Product Code
Date Received
12/11/2012
Decision Date
09/05/2013
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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