510(k) K981116 ยท KYG Device, Irrigation, Ocular Surgery
SOVEREIGN CATARACT EXTRACTION SYSTEM
| Applicant | Allergan, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 19, 1998 |
| Received | Mar 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981116
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2023 | B. Braun Medical, Inc. AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use. Open, Classified |
KYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.