510(k) K211637 ยท GEX Powered Laser Surgical Instrument
AROMA GRAND
| Applicant | Daeju Meditech Engineering Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Sep 3, 2021 |
| Received | May 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211637
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.