FDA 510(k) Application Details - K020886

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K020886
Device Name Ventilator, Non-Continuous (Respirator)
Applicant TYCO HEALTHCARE NANCY
10 ALLEE PELLETIER DOISY
VILLERS-LES-NANCY 54601 FR
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Contact MOUSTAFA ANKI
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 03/18/2002
Decision Date 11/01/2002
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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