LEGAL DOCUMENTS
Certificates & technical documents
Find certificates, device classifications, catalogues and instructions for each product line.
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MISTI implant family
3 registration/declaration records · 9 related documentsApplicable models and configurations are listed in each document.9 / 9 documents
MISTI
Chin implant material
Device classification
PDF · 2 pages · 0.3 MBMISTI
Chin implant material
Instructions for use
PDF · 2 pages · 0.2 MBMISTI
ISO 13485:2016 certificate · KEOSAN
International certificates & records
PDF · 1 pages · 1.0 MBMISTI
Authorization · Nasal and chin implants
Letter of authorization
PDF · 7 pages · 1.5 MBMISTI
Certificate of quality · KS20241217
Origin & quality records
PDF · 1 pages · 0.5 MBMISTI
Nasal implant material
Device classification
PDF · 2 pages · 0.3 MBMISTI
Nasal implant material
Instructions for use
PDF · 2 pages · 0.8 MBMISTI
FDA 510(k) record · K241150
International certificates & records
PDF · 8 pages · 0.5 MBMISTI
Facial implant material
Device classification
PDF · 2 pages · 0.7 MB