The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Stopcock Manifold Gangs.
| Device ID | K962581 |
| 510k Number | K962581 |
| Device Name: | STOPCOCK MANIFOLD GANGS |
| Classification | Stopcock, I.v. Set |
| Applicant | BAXTER HEALTHCARE CORP. RTE. 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Mary Ellen Snyder |
| Correspondent | Mary Ellen Snyder BAXTER HEALTHCARE CORP. RTE. 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 | 1996-07-01 |
| Decision Date | 1996-08-28 |
| Summary: | summary |