The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for Comfort Sleeved All Silicone Foley Catheter.
| Device ID | K905042 |
| 510k Number | K905042 |
| Device Name: | COMFORT SLEEVED ALL SILICONE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | ROCHESTER MEDICAL CORP. 1500 NW 2ND AVE. P.O. BOX 188 Stewartville, MN 55976 |
| Contact | Richard D Fryar |
| Correspondent | Richard D Fryar ROCHESTER MEDICAL CORP. 1500 NW 2ND AVE. P.O. BOX 188 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 | 1990-11-07 |
| Decision Date | 1991-01-18 |