The following data is part of a premarket notification filed by Shantou Wealy Medical Instrument Co., Ltd. with the FDA for Automatically Retractable Safety Syringes With Fixed Needle.
| Device ID | K141640 |
| 510k Number | K141640 |
| Device Name: | AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE |
| Classification | Syringe, Antistick |
| Applicant | SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. 570 SILVERADO DRIVE Lafayette, CA 94549 |
| Contact | Charmaine Henderson |
| Correspondent | Charmaine Henderson SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. 570 SILVERADO DRIVE Lafayette, CA 94549 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-19 |
| Decision Date | 2014-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20386120009272 | K141640 | 000 |
| 20386120009074 | K141640 | 000 |
| 20386120009043 | K141640 | 000 |
| 20386120008978 | K141640 | 000 |
| 20386120008961 | K141640 | 000 |
| 20386120008954 | K141640 | 000 |
| 20386120008947 | K141640 | 000 |
| 20386120008930 | K141640 | 000 |
| 20386120008923 | K141640 | 000 |
| 20386120008916 | K141640 | 000 |
| 06971603580319 | K141640 | 000 |
| 06971603580357 | K141640 | 000 |
| 06971603580340 | K141640 | 000 |
| 06971603580289 | K141640 | 000 |
| 06971603580371 | K141640 | 000 |
| 06971603580517 | K141640 | 000 |
| 06971603580586 | K141640 | 000 |
| 20386120009081 | K141640 | 000 |
| 20386120009098 | K141640 | 000 |
| 20386120009265 | K141640 | 000 |
| 20386120009258 | K141640 | 000 |
| 20386120009241 | K141640 | 000 |
| 20386120009234 | K141640 | 000 |
| 20386120009227 | K141640 | 000 |
| 20386120009210 | K141640 | 000 |
| 20386120009197 | K141640 | 000 |
| 20386120009180 | K141640 | 000 |
| 20386120009173 | K141640 | 000 |
| 20386120009166 | K141640 | 000 |
| 20386120009159 | K141640 | 000 |
| 20386120009142 | K141640 | 000 |
| 20386120009135 | K141640 | 000 |
| 20386120009128 | K141640 | 000 |
| 20386120009111 | K141640 | 000 |
| 20386120009104 | K141640 | 000 |
| 06971603580531 | K141640 | 000 |