510(k) K912355 ยท HGY Pump, Breast, Non-Powered
MOTHERS TOUCH ONE HAND BREAST PUMP
| Applicant | Hollister, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Dec 10, 1993 |
| Received | May 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2015 | Ameda, Inc. Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions).
The Terminated |
HGY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.