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FDA 510(k) Application Details - K082750
Device Classification Name
Septal Stapler/Absorbable Staples
More FDA Info for this Device
510(K) Number
K082750
Device Name
Septal Stapler/Absorbable Staples
Applicant
ENTRIGUE SURGICAL, INC.
12672 SILICON DRIVE
SUITE 150
SAN ANTONIO, TX 78249 US
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Contact
GABRIELE G NIEDERAUER
Other 510(k) Applications for this Contact
Regulation Number
878.4750
More FDA Info for this Regulation Number
Classification Product Code
OLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/2008
Decision Date
01/06/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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