The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Interlink Universal Vial Adapter.
Device ID | K924064 |
510k Number | K924064 |
Device Name: | INTERLINK UNIVERSAL VIAL ADAPTER |
Classification | Set, I.v. Fluid Transfer |
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 | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-12 |
Decision Date | 1993-04-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50085412046414 | K924064 | 000 |
50085412004971 | K924064 | 000 |