The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Extension Set Quest Code #3000.
| Device ID | K800825 |
| 510k Number | K800825 |
| Device Name: | EXTENSION SET QUEST CODE #3000 |
| Classification | Tubing, Fluid Delivery |
| Applicant | QUEST MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-14 |
| Decision Date | 1980-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634624957251 | K800825 | 000 |
| 00634624092198 | K800825 | 000 |
| 20634624092505 | K800825 | 000 |
| 20634624095414 | K800825 | 000 |
| 20634624095438 | K800825 | 000 |
| 00634624095458 | K800825 | 000 |
| 20634624095469 | K800825 | 000 |
| 20634624957019 | K800825 | 000 |
| 20634624957026 | K800825 | 000 |
| 20634624957040 | K800825 | 000 |
| 20634624957071 | K800825 | 000 |
| 20634624957101 | K800825 | 000 |
| 20634624957118 | K800825 | 000 |
| 20634624957125 | K800825 | 000 |
| 20634624957132 | K800825 | 000 |
| 20634624090655 | K800825 | 000 |