Rochester Medical Corp. · Class II · Cleared Jul 8, 1998
| K-number | K981612 |
| Device name | ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER |
| Applicant | Rochester Medical Corp. |
| Product code | EZL |
| Device class | Class II |
| Decision date | Jul 8, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 876.5130 |
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