510(k) K010510 ยท HET Laparoscope, Gynecologic (And Accessories)
BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
| Applicant | A & A Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, May 16, 2001 |
| Received | Feb 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010510
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.