The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for All Silicone Foley Catheter, Two-way Foley Catheter, Three-way Foley Catheter, Two-way Radiopaque Foley Catheter.
| Device ID | K981612 |
| 510k Number | K981612 |
| Device Name: | ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | ROCHESTER MEDICAL CORP. ONE ROCHESTER MEDICAL DR. Stewartville, MN 55976 |
| Contact | Mary Wilen |
| Correspondent | Mary Wilen ROCHESTER MEDICAL CORP. ONE ROCHESTER MEDICAL DR. Stewartville, MN 55976 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-06 |
| Decision Date | 1998-07-08 |
| Summary: | summary |