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FDA 510(k) Application Details - K182743
Device Classification Name
Prosthesis, Tracheal, Preformed/Molded
More FDA Info for this Device
510(K) Number
K182743
Device Name
Prosthesis, Tracheal, Preformed/Molded
Applicant
New Cos Inc.
7100 Euclid Ave, Ste 180
Cleveland, OH 44103 US
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Contact
Keith Grafmeyer
Other 510(k) Applications for this Contact
Regulation Number
878.3720
More FDA Info for this Regulation Number
Classification Product Code
NWA
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More FDA Info for this Product Code
Date Received
09/28/2018
Decision Date
10/23/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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