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510(k) K083418

CPR MASK by Firstar Healthcare Co., Ltd. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2010
Date Received
November 18, 2008
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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