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FDA 510(k) Application Details - K983635
Device Classification Name
Gas-Machine, Anesthesia
More FDA Info for this Device
510(K) Number
K983635
Device Name
Gas-Machine, Anesthesia
Applicant
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD, PA 18969 US
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Contact
GALE E WINARSKY
Other 510(k) Applications for this Contact
Regulation Number
868.5160
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Classification Product Code
BSZ
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More FDA Info for this Product Code
Date Received
10/15/1998
Decision Date
01/11/1999
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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