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510(k) K152521

Seal Rite Non-Rebreathing Valve by The Lifeguard Store, Inc. — Product Code CBP

K152521 is an FDA 510(k) premarket notification submitted by The Lifeguard Store, Inc. for the device "Seal Rite Non-Rebreathing Valve". The FDA issued a decision of Substantially Equivalent on June 3, 2016. 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
June 3, 2016
Date Received
September 3, 2015
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