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510(k) K052458

LIV MEDICA CPR FACE MASK by Liv Medica Products Pvt. , Ltd. — Product Code CBP

K052458 is an FDA 510(k) premarket notification submitted by Liv Medica Products Pvt. , Ltd. for the device "LIV MEDICA CPR FACE MASK". The FDA issued a decision of Substantially Equivalent on July 7, 2006. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2006
Date Received
September 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

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FDA data resources