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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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