The following data is part of a premarket notification filed by The Standard Co., Ltd. with the FDA for Blue Eye (ts-905).
| Device ID | K220434 |
| 510k Number | K220434 |
| Device Name: | Blue Eye (TS-905) |
| Classification | Submucosal Injection Agent |
| Applicant | The Standard Co., Ltd. 120, Gunpocheomdansaneop 2-ro Gunpo-si, KR 15880 |
| Contact | Sung Nam Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine, CA 92612 |
| Product Code | PLL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-15 |
| Decision Date | 2022-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20724995221618 | K220434 | 000 |