FDA 510(k) Application Details - K200190

Device Classification Name Needle, Emergency Airway

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510(K) Number K200190
Device Name Needle, Emergency Airway
Applicant VBM Medizintechnik GmbH
Einsteinstrasse 1
Sulz am Neckar 72172 DE
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Contact Jannika Jaeger
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Regulation Number 868.5090

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Classification Product Code BWC
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Date Received 01/27/2020
Decision Date 10/30/2020
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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