The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for Rochester Medical Corporation Silicone Male External Catheter.
| Device ID | K952082 |
| 510k Number | K952082 |
| Device Name: | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | ROCHESTER MEDICAL CORP. 1500 2ND AVENUE NORTHWEST Stewartville, MN 55976 |
| Contact | Richard D Fryar |
| Correspondent | Richard D Fryar ROCHESTER MEDICAL CORP. 1500 2ND AVENUE NORTHWEST Stewartville, MN 55976 |
| Product Code | EXJ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-03 |
| Decision Date | 1995-07-18 |