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FDA 510(k) Application Details - K961945
Device Classification Name
Tube, Tympanostomy
More FDA Info for this Device
510(K) Number
K961945
Device Name
Tube, Tympanostomy
Applicant
ADVANCED MICROBOTICS CORP.
2611 S.W. 3RD. AVE., SUITE 200
PORTLAND, OR 97201 US
Other 510(k) Applications for this Company
Contact
ANTHONY W HUMPAGE
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
05/20/1996
Decision Date
06/11/1996
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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