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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Intranasal Septal
510(k) Number K113585
Device Name NASAL/EPISTAXIS PACK
Applicant
Cogent Therapeutics, LLC
3637 Bernal Ave.
Pleasanton,  CA  94566
Applicant Contact ANNE WORDEN
Correspondent
Cogent Therapeutics, LLC
3637 Bernal Ave.
Pleasanton,  CA  94566
Correspondent Contact ANNE WORDEN
Regulation Number874.4780
Classification Product Code
LYA  
Subsequent Product Code
EMX  
Date Received12/05/2011
Decision Date 04/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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