The following data is part of a premarket notification filed by Atrion Medical Products, Inc. with the FDA for Atrion Medical Ql Fluid Dispensing Syringe.
| Device ID | K020333 |
| 510k Number | K020333 |
| Device Name: | ATRION MEDICAL QL FLUID DISPENSING SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. Arab, AL 35016 |
| Contact | Dan Clark |
| Correspondent | Dan Clark ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. Arab, AL 35016 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-31 |
| Decision Date | 2002-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000557065 | K020333 | 000 |