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FDA 510(k) Application Details - K011383
Device Classification Name
Tube, Tympanostomy
More FDA Info for this Device
510(K) Number
K011383
Device Name
Tube, Tympanostomy
Applicant
DURECT CORP.
10240 BUBB RD.
CUPERTINO, CA 95014 US
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Contact
JEFF P MILLER
Other 510(k) Applications for this Contact
Regulation Number
874.3880
More FDA Info for this Regulation Number
Classification Product Code
ETD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/07/2001
Decision Date
06/25/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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