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FDA 510(k) Application Details - K030233
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.5440
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Classification Product Code
CAW
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More FDA Info for this Product Code
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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