FDA 510(k), K130581, KONIX STERILE GEL

510(K) Number: K130581
Device Name: KONIX STERILE GEL
Manufacturer: TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
Device Classification Name: media, coupling, ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 03/05/2013
Decision Date: 06/18/2014
Regulation Medical Specialty: Radiology

Total pages: 458
Fully redacted pages: 275
Content pages: 183