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FDA 510(k) Application Details - K001412
Device Classification Name
Conserver, Oxygen
More FDA Info for this Device
510(K) Number
K001412
Device Name
Conserver, Oxygen
Applicant
PRECISION MEDICAL, INC.
300 HELD DR.
NORTHAMPTON, PA 18067 US
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Contact
CONLEY WALLACE
Other 510(k) Applications for this Contact
Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
NFB
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More FDA Info for this Product Code
Date Received
05/04/2000
Decision Date
03/20/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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