The following data is part of a premarket notification filed by Biotop Technology Co., Ltd. with the FDA for Biotop Hooksafe U-100 Insulin Syringe, Models 0.5cc/ml And 1cc/ml.
| Device ID | K062318 |
| 510k Number | K062318 |
| Device Name: | BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML |
| Classification | Syringe, Antistick |
| Applicant | BIOTOP TECHNOLOGY CO., LTD. CHUNG-HSIAO E. ROAD, SEC. 2 12F-2, NO. 130 Taipei, TW 100 |
| Contact | Lydia Lee |
| Correspondent | Lydia Lee BIOTOP TECHNOLOGY CO., LTD. CHUNG-HSIAO E. ROAD, SEC. 2 12F-2, NO. 130 Taipei, TW 100 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-09 |
| Decision Date | 2007-01-03 |
| Summary: | summary |