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FDA 510(k) Application Details - K992608
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K992608
Device Name
Ventilator, Continuous, Facility Use
Applicant
DRAGER, INC.
3136 QUARRY RD.
TELFORD, PA 18969 US
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Contact
HARALD KNEUER
Other 510(k) Applications for this Contact
Regulation Number
868.5895
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Classification Product Code
CBK
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More FDA Info for this Product Code
Date Received
08/04/1999
Decision Date
08/24/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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