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FDA 510(k) Application Details - K080032
Device Classification Name
Cement, Ear, Nose And Throat
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510(K) Number
K080032
Device Name
Cement, Ear, Nose And Throat
Applicant
ENVOY MEDICAL CORPORATION
5000 TOWNSHIP PARKWAY
SAINT PAUL, MN 55110 US
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Contact
BERNARD (BUD) HORWATH
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Regulation Number
872.3275
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Classification Product Code
NEA
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More FDA Info for this Product Code
Date Received
01/07/2008
Decision Date
02/28/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
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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