The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for Silicone Antibacterial Foley Catheter.
| Device ID | K971627 |
| 510k Number | K971627 |
| Device Name: | SILICONE ANTIBACTERIAL FOLEY CATHETER |
| Classification | Catheter, Urological (antimicrobial) And Accessories |
| Applicant | ROCHESTER MEDICAL CORP. ONE ROCHESTER MEDICAL DR. Stewartville, MN 55976 |
| Contact | Richard D Fryar |
| Correspondent | Richard D Fryar ROCHESTER MEDICAL CORP. ONE ROCHESTER MEDICAL DR. Stewartville, MN 55976 |
| Product Code | MJC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-02 |
| Decision Date | 1998-01-13 |
| Summary: | summary |