The following data is part of a premarket notification filed by Betec Medical Science Co., Ltd. with the FDA for Betec Retractable Safety Syringe (5ml).
| Device ID | K031909 |
| 510k Number | K031909 |
| Device Name: | BETEC RETRACTABLE SAFETY SYRINGE (5ML) |
| Classification | Syringe, Antistick |
| Applicant | BETEC MEDICAL SCIENCE CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich BETEC MEDICAL SCIENCE CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-20 |
| Decision Date | 2003-10-07 |
| Summary: | summary |