The following data is part of a premarket notification filed by Good Doctors Co.,ltd. with the FDA for Dr’s Finder Neo.
| Device ID | K171867 |
| 510k Number | K171867 |
| Device Name: | Dr’s Finder NEO |
| Classification | Locator, Root Apex |
| Applicant | Good Doctors Co.,Ltd. #208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu Incheon, KR 21315 |
| Contact | Sungro Joo |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine, CA 92620 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-22 |
| Decision Date | 2018-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800025400125 | K171867 | 000 |