510(k) K970161 ยท KYG Device, Irrigation, Ocular Surgery
HEDGES CORNEAL WETTING PAK
| Applicant | Hedges Cwp, Inc., Cherry Hill NJ, US |
| Decision | Substantially Equivalent, Mar 25, 1997 |
| Received | Jan 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970161
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.