FDA 510(k) Application Details - K022864

Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation

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510(K) Number K022864
Device Name Mixer, Breathing Gases, Anesthesia Inhalation
Applicant SK MED
16000 SHERMAN WAY #224
VAN NUYS, CA 91406 US
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Contact DIPAK GHOSH
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Regulation Number 868.5330

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Classification Product Code BZR
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Date Received 08/28/2002
Decision Date 04/11/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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