The following data is part of a premarket notification filed by Pascal Co., Inc. with the FDA for Banicide Liquid Chemical Sterilant/high-level Disinfectant.
| Device ID | K012889 |
| 510k Number | K012889 |
| Device Name: | BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT |
| Classification | Sterilant, Medical Devices |
| Applicant | PASCAL CO., INC. 1001 G STREET, N.W. SUITE 500 WEST Washington, DC 20001 |
| Contact | David R Joy |
| Correspondent | David R Joy PASCAL CO., INC. 1001 G STREET, N.W. SUITE 500 WEST Washington, DC 20001 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-28 |
| Decision Date | 2003-05-27 |
| Summary: | summary |