510(k) K960089
K960089 is an FDA 510(k) premarket notification submitted by Cottrell, Ltd. for the device "PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR". The FDA issued a decision of Substantially Equivalent on April 4, 1996. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Cottrell, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1996
- Date Received
- January 11, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Physical/Chemical Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type