The following data is part of a premarket notification filed by Guangdong Haiou Medical Apparatus Stock Co., Ltd with the FDA for Disposable Sterile Needle Retractable Safety Syringe.
| Device ID | K141349 |
| 510k Number | K141349 |
| Device Name: | Disposable Sterile Needle Retractable Safety Syringe |
| Classification | Syringe, Antistick |
| Applicant | GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD Mazha Industrial Area, Liusha Town BAIYUN DISTRICT OF GUANGZHOU CITY Puning City, CN 518034 |
| Contact | Salon Chen |
| Correspondent | Salon Chen GHTF Medical & Drug Technology Services Institutions TIANBO OFFICE ROOM 225, SHA TAI ROAD NO. 209 Baiyun District Of Guangzhou City, CN 5100000 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-22 |
| Decision Date | 2015-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530750929 | K141349 | 000 |
| 05391530750202 | K141349 | 000 |
| 05391530750233 | K141349 | 000 |
| 05391530750264 | K141349 | 000 |
| 05391530750295 | K141349 | 000 |
| 05391530750325 | K141349 | 000 |
| 05391530750714 | K141349 | 000 |
| 05391530750745 | K141349 | 000 |
| 05391530750776 | K141349 | 000 |
| 05391530750806 | K141349 | 000 |
| 05391530750837 | K141349 | 000 |
| 05391530750868 | K141349 | 000 |
| 05391530750899 | K141349 | 000 |
| 05391530750172 | K141349 | 000 |