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FDA 510(k) Application Details - K981744
Device Classification Name
Ventilator, Non-Continuous (Respirator)
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510(K) Number
K981744
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
W. KEITH THORNTON, D.D.S.
6131 LUTHER LANE, SUITE 208
DALLAS, TX 75225 US
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Contact
W.KEITH THORNTON
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Regulation Number
868.5905
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Classification Product Code
BZD
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More FDA Info for this Product Code
Date Received
05/18/1998
Decision Date
10/14/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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