The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsino I.v. Administration And Extension Sets.
| Device ID | K101958 |
| 510k Number | K101958 |
| Device Name: | AMSINO I.V. ADMINISTRATION AND 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 | 2010-07-12 |
| Decision Date | 2010-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10383790005743 | K101958 | 000 |
| 40704411004043 | K101958 | 000 |
| 40704411004050 | K101958 | 000 |
| 40704411004067 | K101958 | 000 |
| 40704411004074 | K101958 | 000 |
| 40704411005262 | K101958 | 000 |
| 40704411005279 | K101958 | 000 |
| 40704411005286 | K101958 | 000 |
| 40704411007501 | K101958 | 000 |
| 10304040070915 | K101958 | 000 |
| 10304040070922 | K101958 | 000 |
| 10304040070939 | K101958 | 000 |
| 10304040070946 | K101958 | 000 |
| 10304040070953 | K101958 | 000 |
| 10304040070960 | K101958 | 000 |
| 10383790003367 | K101958 | 000 |
| 10383790003374 | K101958 | 000 |
| 40383790005737 | K101958 | 000 |
| 40704411004036 | K101958 | 000 |