The following data is part of a premarket notification filed by Shinhung Company Ltd with the FDA for Taurus C1.
Device ID | K151996 |
510k Number | K151996 |
Device Name: | TAURUS C1 |
Classification | Unit, Operative Dental |
Applicant | SHINHUNG COMPANY LTD SHINHUNG BLDG, 450 CHEONGPA-RO, JUNG-GU Seoul, KR 100-858 |
Contact | Sky Shin |
Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-20 |
Decision Date | 2016-01-22 |
Summary: | summary |