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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K092107
Device Name VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010
Applicant
Nidacon International AB
333 Milford Rd.
Deerfield,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Nidacon International AB
333 Milford Rd.
Deerfield,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number884.6180
Classification Product Code
MQL  
Date Received07/14/2009
Decision Date 06/15/2010
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 Yes
Predetermined Change
Control Plan Authorized		 No
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