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FDA 510(k) Application Details - K982943
Device Classification Name
Conserver, Oxygen
More FDA Info for this Device
510(K) Number
K982943
Device Name
Conserver, Oxygen
Applicant
TRANSTRACHEAL SYSTEMS
4655 KIRKWOOD COURT
BOULDER, CO 80301 US
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Contact
LEWIS W WARD
Other 510(k) Applications for this Contact
Regulation Number
868.5905
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Classification Product Code
NFB
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More FDA Info for this Product Code
Date Received
08/21/1998
Decision Date
07/12/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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