FDA 510(k) Application Details - K080039

Device Classification Name Apparatus, Gas-Scavenging

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510(K) Number K080039
Device Name Apparatus, Gas-Scavenging
Applicant G. DUNDAS CO.,INC.
24301 ROBERTS DR.
BLACK DIAMOND, WA 98010 US
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Contact MARIO SORCI
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Regulation Number 868.5430

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Classification Product Code CBN
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Date Received 01/07/2008
Decision Date 04/14/2008
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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