The following data is part of a premarket notification filed by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa with the FDA for Konix Sterile Gel.
| Device ID | K130581 |
| 510k Number | K130581 |
| Device Name: | KONIX STERILE GEL |
| Classification | Media, Coupling, Ultrasound |
| Applicant | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA 2237 CHESTNUT STREET San Francisco, CA 94123 |
| Contact | Michael Scott, Regulatory Agent |
| Correspondent | Michael Scott, Regulatory Agent TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA 2237 CHESTNUT STREET San Francisco, CA 94123 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-05 |
| Decision Date | 2014-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479262117 | K130581 | 000 |