510(k) K130581

KONIX STERILE GEL by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa — Product Code MUI

K130581 is an FDA 510(k) premarket notification submitted by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa for the device "KONIX STERILE GEL". The FDA issued a decision of Substantially Equivalent on June 18, 2014. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa has at least 2 other 510(k) clearances on record.