The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Swabsite Swabbable Valve, Model 245000.
| Device ID | K002689 |
| 510k Number | K002689 |
| Device Name: | SWABSITE SWABBABLE VALVE, MODEL 245000 |
| Classification | Set, Administration, Intravascular |
| Applicant | QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Contact | Doug Bryan |
| Correspondent | Doug Bryan QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-29 |
| Decision Date | 2001-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634624031500 | K002689 | 000 |