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FDA 510(k) Application Details - K960309
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K960309
Device Name
Generator, Oxygen, Portable
Applicant
AIRSEP CORP.
290 CREEKSIDE DR.
BUFFALO, NY 14228 US
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Contact
EDWARD E VRANA
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
01/05/1996
Decision Date
02/28/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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