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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 K971188
Device Name SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS
Applicant
Smith & Nephew, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Applicant Contact ELIZABETH A RYAN
Correspondent
Smith & Nephew, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Correspondent Contact ELIZABETH A RYAN
Regulation Number884.1690
Classification Product Code
HIH  
Date Received03/31/1997
Decision Date 06/27/1997
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
Predetermined Change
Control Plan Authorized		 No
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