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510(k) K201756

Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent by Stryker Sustainability Solutions — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2020
Date Received
June 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

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