The following data is part of a premarket notification filed by Atrion Medical Products, Inc. with the FDA for Ql Locking Syringe.
| Device ID | K060643 |
| 510k Number | K060643 |
| Device Name: | QL LOCKING SYRINGE |
| Classification | Syringe, Balloon Inflation |
| 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 | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-10 |
| Decision Date | 2006-07-12 |
| Summary: | summary |