510(k) K970370 ยท FMI Needle, Hypodermic, Single Lumen
TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
| Applicant | Tsk Laboratory, Japan, Tochigi-Shi, Tochigi-Ken, JP |
| Decision | Substantially Equivalent, Apr 10, 1997 |
| Received | Jan 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2011 | Merz Aesthetics, Inc. MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory.
The intended use of the Cannula is the injection Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.