FDA 510(k) Application Details - K082899

Device Classification Name Meter, Peak Flow, Spirometry

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510(K) Number K082899
Device Name Meter, Peak Flow, Spirometry
Applicant DYNAMITECH MEDICAL, INC
PACIFIC NORTHWEST BRANCK
611 S. SCHOOLHOUSE CREEK RD
GRANTS PASS, OR 97526 US
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Contact KEITH LOWREY
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Regulation Number 868.1860

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Classification Product Code BZH
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Date Received 09/30/2008
Decision Date 03/10/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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