510(k) K161346 ยท JOW Sleeve, Limb, Compressible
NormaTec PCD-T and PCD-B
| Applicant | NormaTec Industries, LP, Newton MA, US |
| Decision | Substantially Equivalent, Jun 15, 2016 |
| Received | May 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161346
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.