FDA 510(k) Application Details - K992743

Device Classification Name Spirometer, Diagnostic

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510(K) Number K992743
Device Name Spirometer, Diagnostic
Applicant COLLINS MEDICAL, INC.
220 WOOD RD.
BRAINTREE, MA 02184-2408 US
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Contact DALE F HUBBARD
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 08/16/1999
Decision Date 09/13/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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