510(k) K260346 ยท HGX Pump, Breast, Powered
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
| Applicant | Polybell (Guangzhou) Limited, Guangzhou, CN |
| Decision | Substantially Equivalent, Jun 12, 2026 |
| Received | Feb 3, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260346
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.