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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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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