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510(k) K212860

SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) by STERIS Corporation — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2021
Date Received
September 8, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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