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FDA 510(k) Application Details - K955549
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K955549
Device Name
Generator, Oxygen, Portable
Applicant
OXLIFE, INC.
1432 VISCAYA PKWY.
CAPE CORAL, FL 33990 US
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Contact
STUART BASSINE
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
12/05/1995
Decision Date
03/15/1996
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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