The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for Hydrophilic Silicone Foley Catheter And Personal Catheter (hydrophilic And Non-hydrophilic).
| Device ID | K000723 |
| 510k Number | K000723 |
| Device Name: | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) |
| Classification | Catheter, Urological |
| 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 | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-06 |
| Decision Date | 2000-05-19 |