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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 K190752
Device Name Satisfaite
Applicant
FemmePharma Consumer Healthcare, LLC
175 Strafford Ave., Bldg 4, Suite 275
Wayne,  PA  19087
Applicant Contact Gerianne DiPiano
Correspondent
Emergo by UL
2500 Bee Cave Road; Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/25/2019
Decision Date 12/13/2019
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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