FDA 510(k) Application Details - K771219

Device Classification Name Tube, Bronchial (W/Wo Connector)

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510(K) Number K771219
Device Name Tube, Bronchial (W/Wo Connector)
Applicant MALLINCKRODT CRITICAL CARE

, US
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Regulation Number 868.5720

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Classification Product Code BTS
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Date Received 07/05/1977
Decision Date 08/04/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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