The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsure Foley Catheter.
| Device ID | K030120 |
| 510k Number | K030120 |
| Device Name: | AMSURE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | AMSINO INTERNATIONAL, INC. 4501 BRICKELL PRIVADO ST. Ontario, CA 91761 |
| Contact | Ching Ching Seah |
| Correspondent | Ching Ching Seah AMSINO INTERNATIONAL, INC. 4501 BRICKELL PRIVADO ST. Ontario, CA 91761 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-13 |
| Decision Date | 2003-10-29 |