The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Change In Sterility Test Method & Test Lab. Site.
| Device ID | K872795 |
| 510k Number | K872795 |
| Device Name: | CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | Clint Lawson |
| Correspondent | Clint Lawson MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-08 |
| Decision Date | 1987-09-04 |