510(k) K913077 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
LANCASTER COOLING JACKET, CAT. CODE #13500/13501
| Applicant | Dlp, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Jan 9, 1992 |
| Received | Jul 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913077
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.