The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for Release Nf Antibacterial Foley Catheter, Antibacterial Personal Catheter.
| Device ID | K001143 |
| 510k Number | K001143 |
| Device Name: | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER |
| Classification | Catheter, Urological (antimicrobial) And Accessories |
| 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 | MJC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801741069394 | K001143 | 000 |
| 10801741068291 | K001143 | 000 |
| 10801741068307 | K001143 | 000 |
| 20801741068311 | K001143 | 000 |
| 20801741068328 | K001143 | 000 |
| 20801741068687 | K001143 | 000 |
| 20801741068694 | K001143 | 000 |
| 20801741068700 | K001143 | 000 |
| 20801741068717 | K001143 | 000 |
| 20801741068724 | K001143 | 000 |
| 10801741069076 | K001143 | 000 |
| 20801741069080 | K001143 | 000 |
| 10801741069090 | K001143 | 000 |
| 10801741069106 | K001143 | 000 |
| 20801741069363 | K001143 | 000 |
| 10801741069373 | K001143 | 000 |
| 20801741069387 | K001143 | 000 |
| 20801741068281 | K001143 | 000 |