The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Q2 Intravenous Adminstration Sets And Extension Sets.
| Device ID | K151079 |
| 510k Number | K151079 |
| Device Name: | Q2 Intravenous Adminstration Sets And Extension Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | QUEST MEDICAL, INC. ONE ALLENTOWN PARKWAY Allen, TX 75002 |
| Contact | Amy Clendening-wheeler |
| Correspondent | Amy Clendening-wheeler QUEST MEDICAL, INC. ONE ALLENTOWN PARKWAY 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 | 2015-04-22 |
| Decision Date | 2015-09-30 |
| Summary: | summary |