FDA 510(k) Application Details - K002384

Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase

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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
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Regulation Number 868.1720

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Classification Product Code CCL
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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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