The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Precision Delivery Infusion Set.
| Device ID | K202672 |
| 510k Number | K202672 |
| Device Name: | Precision Delivery Infusion Set |
| 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 | 2020-09-15 |
| Decision Date | 2021-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20634624621163 | K202672 | 000 |
| 20634624621033 | K202672 | 000 |
| 20634624621026 | K202672 | 000 |
| 20634624621019 | K202672 | 000 |
| 20634624922048 | K202672 | 000 |
| 20634624921072 | K202672 | 000 |
| 20634624921065 | K202672 | 000 |
| 20634624921034 | K202672 | 000 |
| 20634624921027 | K202672 | 000 |
| 20634624921010 | K202672 | 000 |
| 20634624621040 | K202672 | 000 |
| 20634624621057 | K202672 | 000 |
| 20634624621064 | K202672 | 000 |
| 20634624621156 | K202672 | 000 |
| 20634624621149 | K202672 | 000 |
| 20634624621132 | K202672 | 000 |
| 20634624621125 | K202672 | 000 |
| 20634624621118 | K202672 | 000 |
| 20634624621101 | K202672 | 000 |
| 20634624621095 | K202672 | 000 |
| 20634624621088 | K202672 | 000 |
| 20634624621071 | K202672 | 000 |
| 20634624911066 | K202672 | 000 |