The following data is part of a premarket notification filed by Amsino International Inc. with the FDA for Puggle Enteral Feeding Pump And Feeding Set.
| Device ID | K200051 |
| 510k Number | K200051 |
| Device Name: | PUGGLE Enteral Feeding Pump And Feeding Set |
| Classification | Pump, Infusion, Enteral |
| Applicant | Amsino International Inc. 708 Corporate Center Drive Pomona, CA 91768 |
| Contact | Jane Gao |
| Correspondent | Jane Gao Amsino International Inc. 708 Corporate Center Drive Pomona, CA 91768 |
| Product Code | LZH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-10 |
| Decision Date | 2020-09-25 |