The following data is part of a premarket notification filed by Great Group Medical Co., Ltd. with the FDA for Ggm Breathing Circuit Bacterial Filter.
| Device ID | K210352 |
| 510k Number | K210352 |
| Device Name: | GGM Breathing Circuit Bacterial Filter |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | Great Group Medical Co., Ltd. No. 168, Xingong 2nd Rd., Tianzhong Township Changhua County, TW 520 |
| Contact | Kiki Hung |
| Correspondent | Kiki Hung Great Group Medical Co., Ltd. No. 168, Xingong 2nd Rd., Tianzhong Township Changhua County, TW 520 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2022-03-27 |