The following data is part of a premarket notification filed by Clariant Corporation with the FDA for Ocide Hospital Cleaner-disinfectant.
Device ID | K945227 |
510k Number | K945227 |
Device Name: | OCIDE HOSPITAL CLEANER-DISINFECTANT |
Classification | Disinfectant, Medical Devices |
Applicant | CLARIANT CORPORATION 3411 SILVERSIDE RD. 104 HAGLEY BUILDING Wilmington, DE 19810 |
Contact | R L Schauer |
Correspondent | R L Schauer CLARIANT CORPORATION 3411 SILVERSIDE RD. 104 HAGLEY BUILDING Wilmington, DE 19810 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-26 |
Decision Date | 1995-03-23 |