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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
510(k) Number K131084
Device Name SASMAR ORIGINAL, SASMAR CLASSIC
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
NUC  
Date Received04/18/2013
Decision Date 09/13/2013
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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