FDA 510(k) Application Details - K062153

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K062153
Device Name Generator, Oxygen, Portable
Applicant MOLECULAR PRODUCTS LTD.
3460 POINTE CREEK CT.
# 102
BONITA SPRINGS, FL 34134 US
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Contact PAUL DRYDEN
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 07/27/2006
Decision Date 11/21/2006
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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