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 |