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FDA 510(k) Application Details - K002384
Device Classification Name
Analyzer, Gas, Oxygen, Gaseous-Phase
More FDA Info for this Device
510(K) Number
K002384
Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant
INTERNATIONAL BUSINESS STRATEGIES
1667A MARSH HABOR LN.
MOUNT PLEASANT, SC 29464 US
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Contact
WILLIAM ROETTGER
Other 510(k) Applications for this Contact
Regulation Number
868.1720
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Classification Product Code
CCL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2000
Decision Date
12/15/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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