The following data is part of a premarket notification filed by Amsino Intl., Inc. with the FDA for Amsure Bladder Irrigation Set.
| Device ID | K070873 |
| 510k Number | K070873 |
| Device Name: | AMSURE BLADDER IRRIGATION SET |
| Classification | System, Irrigation, Urological |
| Applicant | AMSINO INTL., INC. 855 TOWNE CENTER DR. Pomona, CA 91765 |
| Contact | Yi Chen |
| Correspondent | Yi Chen AMSINO INTL., INC. 855 TOWNE CENTER DR. Pomona, CA 91765 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-29 |
| Decision Date | 2007-12-19 |
| Summary: | summary |