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FDA 510(k) Application Details - K983862
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K983862
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
RESPIRATORY SUPPORT PRODUCTS, INC.
2552 MCGAW AVE.
IRVINE, CA 92614 US
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Contact
GORDON SHIGEZAWA
Other 510(k) Applications for this Contact
Regulation Number
868.5450
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Classification Product Code
BTT
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More FDA Info for this Product Code
Date Received
11/02/1998
Decision Date
05/24/1999
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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