The following data is part of a premarket notification filed by Guangdong Intmed Medical Appliance Co., Ltd with the FDA for Safety Auto-disable Syrine With Needle (auto-lock).
| Device ID | K143497 |
| 510k Number | K143497 |
| Device Name: | Safety Auto-Disable Syrine With Needle (Auto-Lock) |
| Classification | Syringe, Antistick |
| Applicant | GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD 1# SOUTH ROAD EUROPE INDUSTRY PARK, SHUNDE DISTRICT Foshan, CN 528300 |
| Contact | Hu Yihan |
| Correspondent | Wang Sanfei GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD 1# SOUTH ROAD EUROPE INDUSTRY PARK, SHUNDE DISTRICT Foshan, CN 528300 |
| Product Code | MEG |
| Subsequent Product Code | FMF |
| Subsequent Product Code | FMI |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-09 |
| Decision Date | 2015-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530750684 | K143497 | 000 |
| 05391530750387 | K143497 | 000 |
| 05391530750417 | K143497 | 000 |
| 05391530750448 | K143497 | 000 |
| 05391530750479 | K143497 | 000 |
| 05391530750509 | K143497 | 000 |
| 05391530750530 | K143497 | 000 |
| 05391530750561 | K143497 | 000 |
| 05391530750592 | K143497 | 000 |
| 05391530750622 | K143497 | 000 |
| 05391530750653 | K143497 | 000 |
| 05391530750356 | K143497 | 000 |