The following data is part of a premarket notification filed by Sunwell Biotech Co., Ltd with the FDA for Auto-disable Sterile Safty Syring For Single Use.
| Device ID | K121637 |
| 510k Number | K121637 |
| Device Name: | AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE |
| Classification | Syringe, Antistick |
| Applicant | SUNWELL BIOTECH CO., LTD 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack SUNWELL BIOTECH 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 | 2012-06-04 |
| Decision Date | 2012-10-25 |
| Summary: | summary |