The following data is part of a premarket notification filed by Biotop Technology Co., Ltd. with the FDA for Biotop Hooksafe Safety Syringe, Models 0.5cc/ml, 1cc/ml, 3cc/ml, 5cc/ml And 10cc/ml.
| Device ID | K041970 |
| 510k Number | K041970 |
| Device Name: | BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML |
| Classification | Syringe, Antistick |
| Applicant | BIOTOP TECHNOLOGY CO., LTD. 58 FU-CHIUN STREET Hsin Chu City, TW 300 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen BIOTOP TECHNOLOGY CO., LTD. 58 FU-CHIUN STREET Hsin Chu City, TW 300 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-22 |
| Decision Date | 2004-08-03 |
| Summary: | summary |