The following data is part of a premarket notification filed by Lepu Medical Technology (beijing) Co., Ltd with the FDA for Shoocin Introducer Kit.
| Device ID | K123475 |
| 510k Number | K123475 |
| Device Name: | SHOOCIN INTRODUCER KIT |
| Classification | Introducer, Catheter |
| Applicant | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD 1531 FELTON ROAD South Euclid, OH 44121 -2722 |
| Contact | Arthur Goddard |
| Correspondent | Arthur Goddard LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD 1531 FELTON ROAD South Euclid, OH 44121 -2722 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2014-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819667020753 | K123475 | 000 |
| 00819667020746 | K123475 | 000 |