The following data is part of a premarket notification filed by Applied Diabetes Research, Incorporated with the FDA for Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109.
| Device ID | K033099 |
| 510k Number | K033099 |
| Device Name: | ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 |
| Classification | Set, Administration, Intravascular |
| Applicant | APPLIED DIABETES RESEARCH, INCORPORATED 28481 LAFALDA Laguna Niguel, CA 92677 |
| Contact | Jim Barley |
| Correspondent | Jim Barley APPLIED DIABETES RESEARCH, INCORPORATED 28481 LAFALDA Laguna Niguel, CA 92677 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-10-16 |
| Summary: | summary |