NASAL/EPISTAXIS PACK— 510(k) K113585

Substantially Equivalent

Cogent Therapeutics, LLC

FDA 510(k) clearance K113585 for NASAL/EPISTAXIS PACK, Substantially Equivalent on 2012-04-25. Applicant: Cogent Therapeutics, LLC. Device class: 1.

Clearance details

Applicant: Cogent Therapeutics, LLC
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2011-12-05
Decision date: 2012-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.