The following data is part of a premarket notification filed by Lk Consulting Group Usa, Inc. with the FDA for Ezdent-i /e2/prora View.
Device ID | K150747 |
510k Number | K150747 |
Device Name: | EzDent-i /E2/Prora View |
Classification | System, Image Processing, Radiological |
Applicant | LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
Contact | Priscilla Chung |
Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-23 |
Decision Date | 2015-04-02 |
Summary: | summary |