FDA 510(k) Application Details - K030233

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K030233
Device Name Generator, Oxygen, Portable
Applicant SIM ITALIA S.R.L.
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 01/23/2003
Decision Date 04/25/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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