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FDA 510(k) Application Details - K031395
Device Classification Name
Ventilator, Emergency, Manual (Resuscitator)
More FDA Info for this Device
510(K) Number
K031395
Device Name
Ventilator, Emergency, Manual (Resuscitator)
Applicant
MERLIN MEDICAL LIMITED
THE WHITBREAD CENTRE,RHYMNEY,
GWENT
UNITED KINGDOM NP22 5BF GB
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Contact
ROGERT STEELE
Other 510(k) Applications for this Contact
Regulation Number
868.5915
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Classification Product Code
BTM
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More FDA Info for this Product Code
Date Received
05/02/2003
Decision Date
07/16/2004
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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