510(k) K012889
K012889 is an FDA 510(k) premarket notification submitted by Pascal Co., Inc. for the device "BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT". The FDA issued a decision of Substantially Equivalent on May 27, 2003. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Pascal Co., Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2003
- Date Received
- August 28, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilant, Medical Devices
- Device Class
- Class II
- Regulation Number
- 880.6885
- Review Panel
- HO
- Submission Type