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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
510(k) Number K003540
Device Name (DISPOSABLE) VAGINAL SPECULUM
Applicant
Feminica, Inc.
3216 Monsabre
Montreal, Quebec,  CA H1N 2L5
Applicant Contact DENIS H DUBOIS
Correspondent
Feminica, Inc.
3216 Monsabre
Montreal, Quebec,  CA H1N 2L5
Correspondent Contact DENIS H DUBOIS
Regulation Number884.4530
Classification Product Code
HIB  
Date Received11/16/2000
Decision Date 02/09/2001
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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