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FDA 510(k) Application Details - K963042
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K963042
Device Name
Generator, Oxygen, Portable
Applicant
SIM ITALIA S.R.L.
55 NORTHERN BLVD., SUITE 410
GREAT NECK, NY 11021 US
Other 510(k) Applications for this Company
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
08/05/1996
Decision Date
11/01/1996
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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