The following data is part of a premarket notification filed by Taiject Medical Device Co., Ltd. with the FDA for Tmd 0.5ml Safety Syringe (fa18 Series 0.5ml/fa58 Series U-100 Insulin/fa78 Series Tuberculin).
| Device ID | K042426 |
| 510k Number | K042426 |
| Device Name: | TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN) |
| Classification | Syringe, Antistick |
| Applicant | TAIJECT MEDICAL DEVICE CO., LTD. P.O. BOX 8853 Newport Beach, CA 92658 |
| Contact | Jim-son Chou |
| Correspondent | Jim-son Chou TAIJECT MEDICAL DEVICE CO., LTD. P.O. BOX 8853 Newport Beach, CA 92658 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-08 |
| Decision Date | 2004-09-22 |
| Summary: | summary |