The following data is part of a premarket notification filed by U & I Corporation with the FDA for L'disq.
| Device ID | K132797 |
| 510k Number | K132797 |
| Device Name: | L'DISQ |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | U & I CORPORATION 20, SANDAN-RO, 76BEON-GIL (RD) Uijeongbu-si, Gyeonggi-do, KR 480-859 |
| Contact | Gyeong-je Kwon |
| Correspondent | Gyeong-je Kwon U & I CORPORATION 20, SANDAN-RO, 76BEON-GIL (RD) Uijeongbu-si, Gyeonggi-do, KR 480-859 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-06 |
| Decision Date | 2014-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800015911856 | K132797 | 000 |
| 08800015911849 | K132797 | 000 |
| 08800015911832 | K132797 | 000 |
| 08800015911825 | K132797 | 000 |
| 08800015911818 | K132797 | 000 |
| 08800015900027 | K132797 | 000 |
| 08800015900010 | K132797 | 000 |
| 08800015900003 | K132797 | 000 |