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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 K041774
Device Name IUR RECIPROCATING MORCELLATOR MODEL # 7210517
Applicant
SMITH & NEPHEW, INC.
150 Minuteman Road
Andover,  MA  01810
Applicant Contact JANICE HASELTON
Correspondent
SMITH & NEPHEW, INC.
150 Minuteman Road
Andover,  MA  01810
Correspondent Contact JANICE HASELTON
Regulation Number884.1690
Classification Product Code
HIH  
Date Received07/01/2004
Decision Date 10/07/2004
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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