FDA 510(k) Application Details - K953269

Device Classification Name Apparatus, Gas-Scavenging

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510(K) Number K953269
Device Name Apparatus, Gas-Scavenging
Applicant ADVANCED WARMING SYSTEMS, INC.
3414 22ND ST.
LUBBOCK, TX 79410 US
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Contact RANDY HICKLE
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Regulation Number 868.5430

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Classification Product Code CBN
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Date Received 07/13/1995
Decision Date 12/20/1996
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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