The following data is part of a premarket notification filed by Diamed Division Ill. Tool Works, Inc. with the FDA for Female External Urinary Appliance.
| Device ID | K823450 |
| 510k Number | K823450 |
| Device Name: | FEMALE EXTERNAL URINARY APPLIANCE |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | DIAMED DIVISION ILL. TOOL WORKS, INC. BURDITT & CALKINS 135 SOUTH LASALLE Chicago , IL 60603 - |
| Contact | R Radzius |
| Correspondent | R Radzius DIAMED DIVISION ILL. TOOL WORKS, INC. BURDITT & CALKINS 135 SOUTH LASALLE Chicago , IL 60603 - |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-17 |
| Decision Date | 1982-12-28 |