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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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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