510(k) K201877 ยท KYZ Syringe, Irrigating (Non Dental)
OtoSet- Ear Cleaning System
| Applicant | Safkan, Inc., Tucson AZ, US |
| Decision | Substantially Equivalent, Nov 5, 2020 |
| Received | Jul 7, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201877
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.