The following data is part of a premarket notification filed by Taiwan Biomaterial Co., Ltd. with the FDA for Twbm Pump.
| Device ID | K180115 |
| 510k Number | K180115 |
| Device Name: | TWBM Pump |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | Taiwan Biomaterial Co., Ltd. 6F, No. 26-1, Sec.2, Shengyi Rd. Zhubei, TW 30261 |
| Contact | Monoj Mon Kalita |
| Correspondent | Monoj Mon Kalita Taiwan Biomaterial Co., Ltd. 6F, No. 26-1, Sec.2, Shengyi Rd. Zhubei, TW 30261 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-07-24 |
| Summary: | summary |