FDA 510(k) Application Details - K020665

Device Classification Name Valve, Non-Rebreathing

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510(K) Number K020665
Device Name Valve, Non-Rebreathing
Applicant SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA, CA 92887-4645 US
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Contact EARL W DRAPER
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Regulation Number 868.5870

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Classification Product Code CBP
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Date Received 03/01/2002
Decision Date 07/30/2002
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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