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FDA 510(k) Application Details - K011861
Device Classification Name
Accessory To Continuous Ventilator (Respirator)
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510(K) Number
K011861
Device Name
Accessory To Continuous Ventilator (Respirator)
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
MOD
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More FDA Info for this Product Code
Date Received
06/14/2001
Decision Date
11/06/2001
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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