The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for Hydrophilic-antibacterial Intermittent Catheter, Intermittent Catheter Closed System Kit.
| Device ID | K033477 |
| 510k Number | K033477 |
| Device Name: | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT |
| Classification | Catheter, Urological (antimicrobial) And Accessories |
| Applicant | ROCHESTER MEDICAL CORP. ONE ROCHESTER MEDICAL DR. Stewartville, MN 55976 |
| Contact | Rob Anglin |
| Correspondent | Rob Anglin 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 | Yes |
| Date Received | 2003-11-03 |
| Decision Date | 2004-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741104111 | K033477 | 000 |
| 10801741069267 | K033477 | 000 |
| 10801741069250 | K033477 | 000 |
| 20801741069240 | K033477 | 000 |
| 20801741069233 | K033477 | 000 |
| 10801741069014 | K033477 | 000 |
| 10801741069007 | K033477 | 000 |
| 20801741068991 | K033477 | 000 |
| 10801741068987 | K033477 | 000 |
| 10801741068543 | K033477 | 000 |
| 20801741068533 | K033477 | 000 |
| 10801741068529 | K033477 | 000 |
| 20801741068519 | K033477 | 000 |
| 10801741068505 | K033477 | 000 |
| 10801741068215 | K033477 | 000 |
| 10801741068208 | K033477 | 000 |
| 10801741068192 | K033477 | 000 |
| 20801741068182 | K033477 | 000 |
| 20801741069707 | K033477 | 000 |
| 20801741069714 | K033477 | 000 |
| 10801741104104 | K033477 | 000 |
| 10801741104098 | K033477 | 000 |
| 10801741104081 | K033477 | 000 |
| 10801741104074 | K033477 | 000 |
| 10801741104067 | K033477 | 000 |
| 10801741104050 | K033477 | 000 |
| 10801741104043 | K033477 | 000 |
| 10801741104036 | K033477 | 000 |
| 10801741104029 | K033477 | 000 |
| 10801741104012 | K033477 | 000 |
| 10801741104005 | K033477 | 000 |
| 10801741103992 | K033477 | 000 |
| 10801741103985 | K033477 | 000 |
| 10801741103978 | K033477 | 000 |
| 10801741069748 | K033477 | 000 |
| 20801741069738 | K033477 | 000 |
| 10801741069724 | K033477 | 000 |
| 20801741068175 | K033477 | 000 |