The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for Hydrosil; Magic; Personal Catheter.
| Device ID | K122785 |
| 510k Number | K122785 |
| Device Name: | HYDROSIL; MAGIC; PERSONAL CATHETER |
| Classification | Catheter, Straight |
| 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 | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-11 |
| Decision Date | 2013-05-14 |
| Summary: | summary |