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510(k) K113585

NASAL/EPISTAXIS PACK by Cogent Therapeutics, LLC — Product Code LYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2012
Date Received
December 5, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Intranasal Septal
Device Class
Class I
Regulation Number
874.4780
Review Panel
EN
Submission Type

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