FDA 510(k) Application Details - K990429

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K990429
Device Name Ventilator, Continuous, Facility Use
Applicant CARDIOPULMONARY CORP.
200 CASCADE BLVD.
MILFORD, CT 06460 US
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Contact JOHN LAVIOLA
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 02/11/1999
Decision Date 02/24/1999
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Special
Reviewed By Third Party N
Expedited Review



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