FDA 510(k) Application Details - K020281

Device Classification Name Resuscitator,Manual,Non Self-Inflating

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510(K) Number K020281
Device Name Resuscitator,Manual,Non Self-Inflating
Applicant VENTLAB CORP.
2934 HWY. 601 NORTH
MOCKSVILLE, NC 27028 US
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Contact MARGE WALLS-WALKER
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Regulation Number 868.5905

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Classification Product Code NHK
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Date Received 01/28/2002
Decision Date 02/11/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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