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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 K984172
Device Name MODIFICATION OF PURESPERM
Applicant
Nidacon International AB
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Nidacon International AB
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number884.6180
Classification Product Code
MQL  
Date Received11/20/1998
Decision Date 01/14/1999
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
Predetermined Change
Control Plan Authorized		 No
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