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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 K191411
Device Name Ah!Yes Ob Coco Personal Lubricant
Applicant
Bio-Tech Lubricants, Ltd.
C/O Epsilon House, Enterprise Rd.,
Southampton Science Park
Southampton,  GB SO16 7NS
Applicant Contact Sarah Brooks
Correspondent
Bio-Tech Lubricants, Ltd.
C/O The Timber Barn, Selborne Rd.
Greatham, Liss,  GB GU33 6HG
Correspondent Contact Karen Cornelius
Regulation Number884.5300
Classification Product Code
NUC  
Date Received05/28/2019
Decision Date 02/06/2020
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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