The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsure 3-way Hydrophilic Latex Foley Catheter.
| Device ID | K101824 |
| 510k Number | K101824 |
| Device Name: | AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. Pomona, CA 91767 |
| Contact | Jesus Farinas |
| Correspondent | Jesus Farinas AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. Pomona, CA 91767 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-09-13 |
| Summary: | summary |