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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 K110766
Device Name KOLPLUX SYSTEM
Applicant
KOLPLAST CI LTDA
1468 Harwell Avenue
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
KOLPLAST CI LTDA
1468 Harwell Avenue
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number884.4530
Classification Product Code
HIB  
Date Received03/18/2011
Decision Date 09/15/2011
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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