510(k) K011519 ยท HGY Pump, Breast, Non-Powered
AMEDA HYGIENIKIT
| Applicant | Hollister, Inc., Libertyville IL, US |
| Decision | Substantially Equivalent, Aug 15, 2001 |
| Received | May 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2015 | Ameda, Inc. Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8. Terminated |
HGY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.