The following data is part of a premarket notification filed by Central Solutions, Inc. with the FDA for Tri-cen Germicidal Detergent.
Device ID | K951020 |
510k Number | K951020 |
Device Name: | TRI-CEN GERMICIDAL DETERGENT |
Classification | Disinfectant, Medical Devices |
Applicant | CENTRAL SOLUTIONS, INC. 3130 BRINKERHOFF RD. Kansas City, KS 66115 |
Contact | Gary W Helton |
Correspondent | Gary W Helton CENTRAL SOLUTIONS, INC. 3130 BRINKERHOFF RD. 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 | 1995-03-07 |
Decision Date | 1995-08-28 |