The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsure Foley Insertion Tray.
| Device ID | K030664 |
| 510k Number | K030664 |
| Device Name: | AMSURE FOLEY INSERTION TRAY |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| 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 | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-03 |
| Decision Date | 2003-05-23 |