The following data is part of a premarket notification filed by Ding Hwa Co., Ltd. with the FDA for Sparmax Aspirator, Models Tc-2000v Nd Vc-701.
| Device ID | K080005 |
| 510k Number | K080005 |
| Device Name: | SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | DING HWA CO., LTD. NO. 6, LANE 29, WENMING RD. Guishan, Taoyuan, TW |
| Contact | Hui-chen Kai |
| Correspondent | Hui-chen Kai DING HWA CO., LTD. NO. 6, LANE 29, WENMING RD. Guishan, Taoyuan, TW |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-02 |
| Decision Date | 2008-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30092237622811 | K080005 | 000 |