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510(k) K112126

GENUINE FIRST AID CPR MASK by Genuine First Aid, LLC — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2011
Date Received
July 25, 2011
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

Other clearances by Genuine First Aid, LLC

  • K102299 — CPR FACE MASK (March 18, 2011)

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