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510(k) K053464

SERVICE MANAGER SM40SE by Conmed Integrated Systems, Canada, Ulc — Product Code FYD

K053464 is an FDA 510(k) premarket notification submitted by Conmed Integrated Systems, Canada, Ulc for the device "SERVICE MANAGER SM40SE". The FDA issued a decision of Substantially Equivalent on June 6, 2006. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2006
Date Received
December 13, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

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FDA data resources