The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Sub-q-set(r) Subcutaneous Infusion Set.
| Device ID | K925362 |
| 510k Number | K925362 |
| Device Name: | SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Marcia Marconi |
| Correspondent | Marcia Marconi BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-22 |
| Decision Date | 1993-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412013485 | K925362 | 000 |