510(k) K960738 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)
| Applicant | Engineered Custom Mfg., Inc., Ridgefield NJ, US |
| Decision | Substantially Equivalent, May 6, 1997 |
| Received | Feb 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2011 | Stryker Endoscopy 45cm Laparoscopic Instruments Sterilization tray.
Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95138
Designed to hold laparoscopic surgical manual instruments which are intend Terminated |
KCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.