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510(k) K113549

COMFORT COUGH by Seoil Pacific Corp. — Product Code NHJ

K113549 is an FDA 510(k) premarket notification submitted by Seoil Pacific Corp. for the device "COMFORT COUGH". The FDA issued a decision of Substantially Equivalent on February 21, 2013. The device falls under product code NHJ (Device, Positive Pressure Breathing, Intermittent), a Class II device regulated under 21 CFR 868.5905.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2013
Date Received
December 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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FDA data resources