510(k) K932922
K932922 is an FDA 510(k) premarket notification submitted by Cottrell, Ltd. for the device "PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR". The FDA issued a decision of Substantially Equivalent on July 3, 1995. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Cottrell, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 1995
- Date Received
- June 15, 1993
- 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