The following data is part of a premarket notification filed by Lifetech Scientific (shenzhen) Co., Ltd. with the FDA for Lawmax Dilator.
| Device ID | K123842 |
| 510k Number | K123842 |
| Device Name: | LAWMAX DILATOR |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. LANGSHAN 2ND STREET NANSHAN DISTRICT Shenzheng, Guangdong, CN 518057 |
| Contact | Lily Shi |
| Correspondent | Lily Shi LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. LANGSHAN 2ND STREET NANSHAN DISTRICT Shenzheng, Guangdong, CN 518057 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-13 |
| Decision Date | 2013-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938370131564 | K123842 | 000 |
| 06938370131557 | K123842 | 000 |
| 06938370131540 | K123842 | 000 |
| 06938370131533 | K123842 | 000 |
| 06938370131526 | K123842 | 000 |
| 06938370131519 | K123842 | 000 |