FDA 510(k) Application Details - K061785

Device Classification Name Regulator, Pressure, Gas Cylinder

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510(K) Number K061785
Device Name Regulator, Pressure, Gas Cylinder
Applicant RESPONSIVE RESPIRATORY INC.
261 WOLFNER DRIVE
FENTON, MO 63026 US
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Contact THOMAS BANNON
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Regulation Number 868.2700

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Classification Product Code CAN
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Date Received 06/23/2006
Decision Date 09/07/2006
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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