510(k) K041833

CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER by Consolidated Machine Corp. — Product Code FLE

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)