The following data is part of a premarket notification filed by Huntington Laboratories, Inc. with the FDA for Beaucoup General Purpose Disinfectant.
Device ID | K960580 |
510k Number | K960580 |
Device Name: | BEAUCOUP GENERAL PURPOSE DISINFECTANT |
Classification | Disinfectant, Medical Devices |
Applicant | HUNTINGTON LABORATORIES, INC. 970 E. TIPTON ST. Huntington, IN 46750 |
Contact | Sally Hayes |
Correspondent | Sally Hayes HUNTINGTON LABORATORIES, INC. 970 E. TIPTON ST. Huntington, IN 46750 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-12 |
Decision Date | 1996-03-12 |