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FDA 510(k) Application Details - K991670
Device Classification Name
Tube, Tympanostomy
More FDA Info for this Device
510(K) Number
K991670
Device Name
Tube, Tympanostomy
Applicant
MICROMEDICS, INC.
1285 CORPORATE CENTER DR.,
#150
EAGAN, MN 55121 US
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Contact
CHARLES GROTE
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
05/17/1999
Decision Date
08/26/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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