510(k) K915876 ยท IME Pack, Hot Or Cold, Reusable
HOTPAD
| Applicant | Ten Comfort Corp., Taiwan R.O.C., CN |
| Decision | Substantially Equivalent, Feb 12, 1993 |
| Received | Dec 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915876
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.