510(k) K012889 ยท MED Sterilant, Medical Devices
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
| Applicant | Pascal Co., Inc., Washington DC, US |
| Decision | Substantially Equivalent, May 27, 2003 |
| Received | Aug 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2005 | Pascal Co Inc product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Man Terminated |
MED | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.