The following data is part of a premarket notification filed by Biotop Technology Co., Ltd. with the FDA for Biotop Hooksafe Luer-lock Safety Syringe, Models 3cc/ml, 5cc/ml And 10cc/ml.
| Device ID | K043038 |
| 510k Number | K043038 |
| Device Name: | BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML |
| Classification | Syringe, Antistick |
| Applicant | BIOTOP TECHNOLOGY CO., LTD. 12 F-2, NO. 130 CHUNG-HSIAO E.ROAD,SEC.2 Taipei, TW 100 |
| Contact | Mark Lien |
| Correspondent | Mark Lien BIOTOP TECHNOLOGY CO., LTD. 12 F-2, NO. 130 CHUNG-HSIAO E.ROAD,SEC.2 Taipei, TW 100 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-04 |
| Decision Date | 2004-12-22 |
| Summary: | summary |