510(k) K840568 ยท EXB Collector, Ostomy
ACTIVE LIFE ONE-PIECE CLOSED-END POUCH
| Applicant | Convatec, A Division of E.R. Squibb & Sons, Mchenry IL, US |
| Decision | Substantially Equivalent, May 2, 1984 |
| Received | Feb 8, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840568
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2006 | ConvaTec ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15)
1 3/4 in. 45 mm Terminated |
LNO | None listed |
| Sep 27, 2006 | ConvaTec ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60)
1 3/4 in. 45 mm Terminated |
LNO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.