FDA 510(k) Application Details - K953230

Device Classification Name Valve, Non-Rebreathing

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510(K) Number K953230
Device Name Valve, Non-Rebreathing
Applicant FORMOSA-CJ HEALTH BUSINESS CORP.
6329 W. WATERVIEW CT.
MCCORDSVILLE, IN 46055-9501 US
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Contact PAUL E DRYDEN
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Regulation Number 868.5870

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Classification Product Code CBP
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Date Received 07/10/1995
Decision Date 02/14/1996
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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