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
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Regulation Number 868.5895

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Classification Product Code MOD
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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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