FDA 510(k) Application Details - K964939

Device Classification Name Calculator, Pulmonary Function Data

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510(K) Number K964939
Device Name Calculator, Pulmonary Function Data
Applicant CREATIVE BIOMEDICS, INC.
934-B CALLE NEGOCIO
SAN CLEMENTE, CA 92673 US
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Contact DANIEL BROWN
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Regulation Number 868.1880

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Classification Product Code BZC
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Date Received 12/10/1996
Decision Date 03/06/1997
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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