The following data is part of a premarket notification filed by Concord/portex with the FDA for Vacu-pro.
| Device ID | K922445 |
| 510k Number | K922445 |
| Device Name: | VACU-PRO |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Robert Wheeler |
| Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-22 |
| Decision Date | 1992-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688028963 | K922445 | 000 |
| 30351688024569 | K922445 | 000 |
| 30351688007951 | K922445 | 000 |
| 10888277929449 | K922445 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VACU-PRO 74294659 not registered Dead/Abandoned |
Smiths Industries Medical Systems, Inc. 1992-07-16 |