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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K936071
Device Name SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
Applicant
Smith & Nephew Dyonics, Inc.
4533 Enterprise Dr.
Oklahoma City,  OK  73128
Applicant Contact STEVEN L JACKSON
Correspondent
Smith & Nephew Dyonics, Inc.
4533 Enterprise Dr.
Oklahoma City,  OK  73128
Correspondent Contact STEVEN L JACKSON
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
GCJ  
Date Received12/20/1993
Decision Date 08/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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