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FDA 510(k) Application Details - K981078
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K981078
Device Name
Generator, Oxygen, Portable
Applicant
TRANSTRACHEAL SYSTEMS
4655 KIRKWOOD COURT
BOULDER, CO 80301 US
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Contact
LEWIS WARD
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Regulation Number
868.5440
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Classification Product Code
CAW
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More FDA Info for this Product Code
Date Received
03/24/1998
Decision Date
07/23/1998
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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