The following data is part of a premarket notification filed by Atrion Medical Products, Inc. with the FDA for Atrion Epidural Anesthesia Kit With Atrion Needlevise Sharps Securing System.
| Device ID | K041158 |
| 510k Number | K041158 |
| Device Name: | ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM |
| Classification | Anesthesia Conduction Kit |
| 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 | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-06-16 |
| Summary: | summary |