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FDA 510(k) Application Details - K955047
Device Classification Name
Attachment, Breathing, Positive End Expiratory Pressure
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510(K) Number
K955047
Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Applicant
WESTMED INTL.
3351 EAST HEMISPHERE LOOP
TUCSON, AZ 85706 US
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Contact
LYNN D HAYSE
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Regulation Number
868.5965
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Classification Product Code
BYE
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More FDA Info for this Product Code
Date Received
11/03/1995
Decision Date
03/27/1996
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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