FDA 510(k) Application Details - K051177

Device Classification Name Ventilator, Emergency, Manual (Resuscitator)

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510(K) Number K051177
Device Name Ventilator, Emergency, Manual (Resuscitator)
Applicant DAVID MEDICAL PRODUCTS CO.,LTD
88 FUDA RD. LUDU
TAICANG,SUZHOU,JIANGSU 215412 CN
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Contact DAVID LU
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Regulation Number 868.5915

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Classification Product Code BTM
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Date Received 05/06/2005
Decision Date 08/29/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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