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FDA 510(k) Application Details - K010401
Device Classification Name
Accessory To Continuous Ventilator (Respirator)
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510(K) Number
K010401
Device Name
Accessory To Continuous Ventilator (Respirator)
Applicant
THE MEDICAL DEVICE GROUP, INC.
PO BOX 4341
CROFTON, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
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
02/12/2001
Decision Date
10/30/2002
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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