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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K201756
Device Name 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
Applicant
Stryker Sustainability Solutions
1810 W Drake Drive
Tempe,  AZ  85283
Applicant Contact Scott English
Correspondent
Stryker Sustainability Solutions
1810 W Drake Drive
Tempe,  AZ  85283
Correspondent Contact Scott English
Regulation Number884.1690
Classification Product Code
HIH  
Date Received06/29/2020
Decision Date 09/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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