The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for All Silicone Foley Catheter.
| Device ID | K896053 |
| 510k Number | K896053 |
| Device Name: | ALL SILICONE FOLEY CATHETER |
| Classification | Catheter, Urological |
| Applicant | ROCHESTER MEDICAL CORP. 210 WOODLAKE DRIVE SE Rochester, MN 55904 |
| Contact | R. D Fryar |
| Correspondent | R. D Fryar ROCHESTER MEDICAL CORP. 210 WOODLAKE DRIVE SE Rochester, MN 55904 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-18 |
| Decision Date | 1990-02-12 |