FDA 510(k) Application Details - K000859

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K000859
Device Name Gas-Machine, Anesthesia
Applicant CHARLES A. SMITH
811 STARLITE DR.
LOUISVILLE, KY 40207 US
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Contact CHARLES A SMITH
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 03/17/2000
Decision Date 08/23/2000
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

FDA Source Information for K000859


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