FDA 510(k) Application Details - K960587

Device Classification Name Valve, Non-Rebreathing

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510(K) Number K960587
Device Name Valve, Non-Rebreathing
Applicant CERTIFIED SAFETY MFG., INC.
1400 CHESTNUT
KANSAS CITY, MO 64127 US
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Contact HOWARD GERSON
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Regulation Number 868.5870

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Classification Product Code CBP
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Date Received 02/12/1996
Decision Date 07/21/1997
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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