The following data is part of a premarket notification filed by Shantou Wealy Medical Instrument Co., Ltd. with the FDA for Automatically Retractable Safety Syringe (with Fixed Needle).
| Device ID | K113587 |
| 510k Number | K113587 |
| Device Name: | AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) |
| Classification | Syringe, Antistick |
| Applicant | SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-05 |
| Decision Date | 2012-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20386120009289 | K113587 | 000 |
| 20386120009067 | K113587 | 000 |
| 20386120009050 | K113587 | 000 |
| 20386120009036 | K113587 | 000 |
| 20386120009029 | K113587 | 000 |
| 20386120009012 | K113587 | 000 |
| 20386120009005 | K113587 | 000 |
| 20386120008992 | K113587 | 000 |
| 20386120008985 | K113587 | 000 |