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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 K152143
Device Name TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
Applicant
SMITH & NEPHEW, INC.
150 Minuteman Road
Andover,  MA  01810
Applicant Contact Bradley Heil
Correspondent
SMITH & NEPHEW, INC.
150 Minuteman Road
Andover,  MA  01810
Correspondent Contact Bradley Heil
Regulation Number884.1690
Classification Product Code
HIH  
Date Received08/03/2015
Decision Date 09/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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