The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for 3 Port Adapter.
Device ID | K913627 |
510k Number | K913627 |
Device Name: | 3 PORT ADAPTER |
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 | 1991-08-15 |
Decision Date | 1991-09-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50085412048500 | K913627 | 000 |