The following data is part of a premarket notification filed by Anest Iwata Sparmax Co., Ltd. with the FDA for Cliq Aspirator.
| Device ID | K201203 |
| 510k Number | K201203 |
| Device Name: | Cliq Aspirator |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | Anest Iwata Sparmax Co., Ltd. 4B-03 Taipei World Trade Center, 4F, No.5, Sec.5, HsinYi Rd Taipei, TW 11011 |
| Contact | Lika Lo |
| Correspondent | Robert O. Dean Compliance Systems International, LLC 1083 Delaware Ave. Buffalo, NY 14223 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-04 |
| Decision Date | 2020-09-03 |