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FDA 510(k) Application Details - K984481
Device Classification Name
Valve, Non-Rebreathing
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510(K) Number
K984481
Device Name
Valve, Non-Rebreathing
Applicant
INTERSURGICAL, INC.
417 ELECTRONICS PKWY.
LIVERPOOL, NY 13088 US
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Contact
THOMAS R GUNERMAN
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Regulation Number
868.5870
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Classification Product Code
CBP
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More FDA Info for this Product Code
Date Received
12/16/1998
Decision Date
01/29/1999
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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