The following data is part of a premarket notification filed by Central Solutions, Inc. with the FDA for Pro-tech.
Device ID | K955850 |
510k Number | K955850 |
Device Name: | PRO-TECH |
Classification | Disinfectant, Medical Devices |
Applicant | CENTRAL SOLUTIONS, INC. 3130 BRINKERHOFF RD. P.O. BOX 15276 Kansas City, KS 66115 |
Contact | Paul J Nobrega |
Correspondent | Paul J Nobrega 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 | 1995-12-27 |
Decision Date | 1996-02-09 |