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510(k) K081516

MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT by Medsource International, LLC — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2008
Date Received
May 30, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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