510(k) K041833
K041833 is an FDA 510(k) premarket notification submitted by Consolidated Machine Corp. for the device "CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on Dec 10, 2004. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Consolidated Machine Corp. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 10, 2004
- Date Received
- Jul 7, 2004
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type
- 510(k)