The following data is part of a premarket notification filed by Ashai Co. Ltd. with the FDA for Uri-sure.
| Device ID | K852619 |
| 510k Number | K852619 |
| Device Name: | URI-SURE |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | ASHAI CO. LTD. 620 HARRIS ST. ULTIMO, N.S.W. 2007 Australia, AU |
| Contact | Kalnin |
| Correspondent | Kalnin ASHAI CO. LTD. 620 HARRIS ST. ULTIMO, N.S.W. 2007 Australia, AU |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-20 |
| Decision Date | 1985-08-27 |