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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lubricant, personal, gamete, fertilization, and embryo compatible
510(k) Number K131355
Device Name CONCEIVE PLUS
Applicant
SASMAR INC
155 NORTH WACKER DR, STE 4250
CHICAGO,  IL  60606
Applicant Contact JOHN-MICHAEL MANCINI
Correspondent
SASMAR INC
155 NORTH WACKER DR, STE 4250
CHICAGO,  IL  60606
Correspondent Contact JOHN-MICHAEL MANCINI
Regulation Number884.5300
Classification Product Code
PEB  
Date Received05/10/2013
Decision Date 11/07/2013
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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