FDA 510(k) Application Details - K033028

Device Classification Name Apparatus, Gas-Scavenging

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510(K) Number K033028
Device Name Apparatus, Gas-Scavenging
Applicant AXON MEDICAL
2355 SOUTH 1170 WEST
SUITE D
SALT LAKE CITY, UT 84119 US
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Contact JOSEPH ORR
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Regulation Number 868.5430

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Classification Product Code CBN
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Date Received 09/26/2003
Decision Date 07/22/2005
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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