The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Quest Vein Graft Perfusion Set.
| Device ID | K952531 |
| 510k Number | K952531 |
| Device Name: | QUEST VEIN GRAFT PERFUSION SET |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Contact | Drew Johnson |
| Correspondent | Drew Johnson QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-01 |
| Decision Date | 1995-08-24 |