510(k) K090979 ยท GCJ Laparoscope, General & Plastic Surgery
DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES
| Applicant | Encision, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, May 28, 2009 |
| Received | Apr 7, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090979
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.