510(k) K962246 ยท HET Laparoscope, Gynecologic (And Accessories)
RIGID FIBER OPTIC LAPAROSCOPE
| Applicant | Health Care International Assoc., Villa Park CA, US |
| Decision | Substantially Equivalent, Feb 7, 1997 |
| Received | Jun 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962246
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.