The following data is part of a premarket notification filed by Coeur, Inc. with the FDA for Disposable Transfer Sets With And Without Swabbable Valves And/or Check Valves.
| Device ID | K063114 |
| 510k Number | K063114 |
| Device Name: | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES |
| Classification | Tubing, Fluid Delivery |
| Applicant | COEUR, INC. 704 CADET COURT Lebanon, TN 37087 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning COEUR, INC. 704 CADET COURT Lebanon, TN 37087 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-11 |
| Decision Date | 2007-02-09 |
| Summary: | summary |