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FDA 510(k) Application Details - K053564
Device Classification Name
Vaporizer, Anesthesia, Non-Heated
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510(K) Number
K053564
Device Name
Vaporizer, Anesthesia, Non-Heated
Applicant
PENLON LIMITED
25 BARKER CLOSE
FISHBOURNE, CHICHESTER
WEST SUSSEX PO18 8BJ GB
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Contact
BARRY PEARCE
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Regulation Number
868.5880
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Classification Product Code
CAD
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More FDA Info for this Product Code
Date Received
12/22/2005
Decision Date
03/03/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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