510(k) K914153 ยท HIF Insufflator, Laparoscopic
OTT INSUFFLATOR FILTER PLUS/TUBING SET
| Applicant | Marlo Surgical Technology, Willoughby OH, US |
| Decision | Substantially Equivalent, Apr 2, 1992 |
| Received | Sep 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914153
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.