The following data is part of a premarket notification filed by Central Solutions, Inc. with the FDA for Q4.5-5.0pb-4.5.
| Device ID | K951342 |
| 510k Number | K951342 |
| Device Name: | Q4.5-5.0PB-4.5 |
| Classification | Disinfectant, Medical Devices |
| Applicant | CENTRAL SOLUTIONS, INC. 3130 BRINKERHOFF RD. P.O. BOX 15276 Kansas City, KS 66115 |
| Contact | Gary W Helton |
| Correspondent | Gary W Helton CENTRAL SOLUTIONS, INC. 3130 BRINKERHOFF RD. P.O. BOX 15276 Kansas City, KS 66115 |
| Product Code | LRJ |
| CFR Regulation Number | 880.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-23 |
| Decision Date | 1995-04-25 |