The following data is part of a premarket notification filed by Avail Medical Products, Inc. with the FDA for Medtronic Minimed Sof-site Infusion Set, Models Mmt-359s6, Mmt-359m6, Mmt-359l6, Mmt-359s9, Mmt-359m9, And Mmt-359l9.
| Device ID | K030149 |
| 510k Number | K030149 |
| Device Name: | MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 |
| Classification | Set, Administration, Intravascular |
| Applicant | AVAIL MEDICAL PRODUCTS, INC. 1900 CARNEGIE AVE. Santa Ana, CA 92705 |
| Contact | Carroll Councilman |
| Correspondent | Carroll Councilman AVAIL MEDICAL PRODUCTS, INC. 1900 CARNEGIE AVE. Santa Ana, CA 92705 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-15 |
| Decision Date | 2003-03-20 |
| Summary: | summary |