The following data is part of a premarket notification filed by Taiwan Biomaterial Co., Ltd. with the FDA for Zoom Aspiration Pump.
| Device ID | K190105 |
| 510k Number | K190105 |
| Device Name: | ZOOM Aspiration 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-22 |
| Decision Date | 2019-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719876940025 | K190105 | 000 |
| 04719876940018 | K190105 | 000 |
| 04719876940001 | K190105 | 000 |
| 04719876940117 | K190105 | 000 |
| 04719876940100 | K190105 | 000 |
| 04719876940094 | K190105 | 000 |
| 04719876940124 | K190105 | 000 |