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FDA 510(k) Application Details - K973051
Device Classification Name
Vaporizer, Anesthesia, Non-Heated
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510(K) Number
K973051
Device Name
Vaporizer, Anesthesia, Non-Heated
Applicant
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD, PA 18969 US
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Contact
JAMES J BRENNAN
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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
08/15/1997
Decision Date
10/30/1997
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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