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FDA 510(k) Application Details - K090455
Device Classification Name
Prosthesis, Laryngeal (Taub)
More FDA Info for this Device
510(K) Number
K090455
Device Name
Prosthesis, Laryngeal (Taub)
Applicant
ATOS MEDICAL AB
KRAFTGATAN 8
HORBY SE-24222 SE
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Contact
FERENC DAHNER
Other 510(k) Applications for this Contact
Regulation Number
874.3730
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Classification Product Code
EWL
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More FDA Info for this Product Code
Date Received
02/23/2009
Decision Date
06/05/2009
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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