The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Q2 Blood Administration Sets.
| Device ID | K213846 |
| 510k Number | K213846 |
| Device Name: | Q2 Blood Administration Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 |
| Contact | Tosan Eweka |
| Correspondent | Tosan Eweka 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 | 2021-12-10 |
| Decision Date | 2022-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20634624921218 | K213846 | 000 |
| 20634624921201 | K213846 | 000 |