The following data is part of a premarket notification filed by Rochester Medical Corp. with the FDA for Male External Catheter.
| Device ID | K923136 |
| 510k Number | K923136 |
| Device Name: | MALE EXTERNAL CATHETER |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | ROCHESTER MEDICAL CORP. 1500 NW 2ND AVE. P.O. BOX 188 Stewartville, MN 55976 |
| Contact | Richard D Fryar |
| Correspondent | Richard D Fryar ROCHESTER MEDICAL CORP. 1500 NW 2ND AVE. P.O. BOX 188 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 | 1992-06-29 |
| Decision Date | 1992-12-03 |