FDA 510(k) Application Details - K961945

Device Classification Name Tube, Tympanostomy

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510(K) Number K961945
Device Name Tube, Tympanostomy
Applicant ADVANCED MICROBOTICS CORP.
2611 S.W. 3RD. AVE., SUITE 200
PORTLAND, OR 97201 US
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Contact ANTHONY W HUMPAGE
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Regulation Number 874.3880

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Classification Product Code ETD
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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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