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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal, Fiberoptic
510(k) Number K923656
Device Name LIGHTING SOURCE SYSTEM
Applicant
Galenica Enterprises, Inc.
C.P. 13
Ste-Therese
Quebec Canada J7e 4h7,  CA
Applicant Contact BETTY MAILOT
Correspondent
Galenica Enterprises, Inc.
C.P. 13
Ste-Therese
Quebec Canada J7e 4h7,  CA
Correspondent Contact BETTY MAILOT
Regulation Number884.4530
Classification Product Code
HIC  
Date Received07/13/1992
Decision Date 09/08/1994
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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