510(k) K002937
K002937 is an FDA 510(k) premarket notification submitted by Albert Browne , Ltd. for the device "TST CONTROL INTEGRATOR FOR STEAM STERILIZERS". The FDA issued a decision of Substantially Equivalent on November 5, 2001. The device falls under product code LRT (Indicator, Sterilization), a Class II device regulated under 21 CFR 880.2800. Albert Browne , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2001
- Date Received
- September 21, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Sterilization
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type