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FDA 510(k) Application Details - K082188
Device Classification Name
Tube, Tympanostomy
More FDA Info for this Device
510(K) Number
K082188
Device Name
Tube, Tympanostomy
Applicant
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK, CA 94025 US
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Contact
KERI YEN
Other 510(k) Applications for this Contact
Regulation Number
874.3880
More FDA Info for this Regulation Number
Classification Product Code
ETD
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More FDA Info for this Product Code
Date Received
08/04/2008
Decision Date
09/19/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
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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