The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Multi-port Manifold.
Device ID | K932512 |
510k Number | K932512 |
Device Name: | MULTI-PORT MANIFOLD |
Classification | Stopcock, I.v. Set |
Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
Contact | Ellen Snyder |
Correspondent | Ellen Snyder BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-25 |
Decision Date | 1994-02-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50085412071720 | K932512 | 000 |
50085412071713 | K932512 | 000 |
50085412036866 | K932512 | 000 |
50085412035470 | K932512 | 000 |
50085412035456 | K932512 | 000 |