The following data is part of a premarket notification filed by Good Doctors Co., Ltd. with the FDA for Dr's Finder.
Device ID | K151274 |
510k Number | K151274 |
Device Name: | Dr's Finder |
Classification | Locator, Root Apex |
Applicant | GOOD DOCTORS CO., LTD. #208, Woolim Lions Valley B-dong, 283 Bupyeong-daero Bupyeong-gu Incheon, KR 403-911 |
Contact | Sungro Joo |
Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
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 | 2015-05-13 |
Decision Date | 2016-02-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
18800025400118 | K151274 | 000 |
08800025400531 | K151274 | 000 |
08800025400524 | K151274 | 000 |