510(k) K972185 ยท FRO Dressing, Wound, Drug
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE
| Applicant | Steripak, Ltd., Runcorn, Cheshire, GB |
| Decision | Substantially Equivalent for Some Indications, Mar 5, 1998 |
| Received | Jun 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972185
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.