510(k) K130959 ยท OLR Oral Wound Dressing
AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL
| Applicant | Bioplax Limited, Bellingham WA, US |
| Decision | Substantially Equivalent, Apr 4, 2014 |
| Received | Apr 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130959
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.