The following data is part of a premarket notification filed by Amsino Intl., Inc. with the FDA for Amsino Urinary Drainage Bag.
| Device ID | K964745 |
| 510k Number | K964745 |
| Device Name: | AMSINO URINARY DRAINAGE BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | AMSINO INTL., INC. 833 TOWNE CENTER DR. Pomona, CA 91767 |
| Contact | Richard Y Li, Ph.d. |
| Correspondent | Richard Y Li, Ph.d. AMSINO INTL., INC. 833 TOWNE CENTER DR. Pomona, CA 91767 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-26 |
| Decision Date | 1997-03-18 |