The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Multiport Manifold Set With Swabable Valves, Model 9900.
| Device ID | K040385 |
| 510k Number | K040385 |
| Device Name: | MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 |
| Classification | Set, Administration, Intravascular |
| Applicant | QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Contact | Kathryn J Thompson |
| Correspondent | Jeremi Peck UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-04-07 |
| Summary: | summary |