The following data is part of a premarket notification filed by Wuxi Yushou Medical Applicances Co., Ltd with the FDA for Safety Syringe.
| Device ID | K053519 |
| 510k Number | K053519 |
| Device Name: | SAFETY SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | WUXI YUSHOU MEDICAL APPLICANCES CO., LTD 2200 NORTHWESTERN AVE. Racine, WI 53404 |
| Contact | Gary Pond |
| Correspondent | Gary Pond WUXI YUSHOU MEDICAL APPLICANCES CO., LTD 2200 NORTHWESTERN AVE. Racine, WI 53404 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-19 |
| Decision Date | 2006-08-11 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SAFETY SYRINGE 74047054 not registered Dead/Abandoned |
Schafer Systems Inc. 1990-04-09 |
![]() SAFETY SYRINGE 74021185 not registered Dead/Abandoned |
Mediverse Inc. 1990-01-22 |