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FDA 510(k) Application Details - K960477
Device Classification Name
Tube, Tympanostomy
More FDA Info for this Device
510(K) Number
K960477
Device Name
Tube, Tympanostomy
Applicant
SMITH & NEPHEW, INC.
555 13TH ST., N.W.
WASHINGTON, DC 20004 US
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Contact
HOWARD M HOLSTEIN
Other 510(k) Applications for this Contact
Regulation Number
874.3880
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Classification Product Code
ETD
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More FDA Info for this Product Code
Date Received
02/01/1996
Decision Date
02/26/1996
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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