The following data is part of a premarket notification filed by Merits Health Products Co., Ltd. with the FDA for Pioneer U601 Series Aspirator.
| Device ID | K052650 |
| 510k Number | K052650 |
| Device Name: | PIONEER U601 SERIES ASPIRATOR |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MERITS HEALTH PRODUCTS CO., LTD. 9, ROAD 36 TAICHUNG INDUSTRIAL PARK Taichung, TW 407 |
| Contact | Steve Chao |
| Correspondent | Steve Chao MERITS HEALTH PRODUCTS CO., LTD. 9, ROAD 36 TAICHUNG INDUSTRIAL PARK Taichung, TW 407 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2005-11-04 |
| Summary: | summary |