The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsino I.v. Administration Set, Amsafe3 I.v Administration Set, Extension Sets.
| Device ID | K093773 |
| 510k Number | K093773 |
| Device Name: | AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-08 |
| Decision Date | 2010-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40704411012185 | K093773 | 000 |
| 40704411012178 | K093773 | 000 |