Adapta Medical, Inc. · Class II · Cleared Aug 16, 2016
| K-number | K161445 |
| Device name | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C |
| Applicant | Adapta Medical, Inc. |
| Product code | EZD |
| Device class | Class II |
| Decision date | Aug 16, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 876.5130 |
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