The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsure Pvc Intermittent Catheter.
| Device ID | K091306 |
| 510k Number | K091306 |
| Device Name: | AMSURE PVC INTERMITTENT CATHETER |
| Classification | Catheter, Straight |
| Applicant | AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. Pomona, CA 91767 |
| Contact | Holiven Ji |
| Correspondent | Holiven Ji AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. Pomona, CA 91767 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-04 |
| Decision Date | 2009-08-21 |
| Summary: | summary |