FDA 510(k) Application Details - K993528

Device Classification Name Valve, Non-Rebreathing

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510(K) Number K993528
Device Name Valve, Non-Rebreathing
Applicant RUSCH, INC.
2450 MEADOWBROOK PKWY.
DULUTH, GA 30096 US
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Contact RONALD YOUNG
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Regulation Number 868.5870

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Classification Product Code CBP
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Date Received 10/18/1999
Decision Date 05/31/2000
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



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