The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsure Disposable Syringe With/without Needle.
| Device ID | K061039 |
| 510k Number | K061039 |
| Device Name: | AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE |
| Classification | Syringe, Piston |
| Applicant | AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. Pomona, CA 91767 |
| Contact | Ching Ching Seah |
| Correspondent | Ching Ching Seah AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. Pomona, CA 91767 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-14 |
| Decision Date | 2006-06-29 |
| Summary: | summary |