Ah!Yes Ob Coco Personal Lubricant

Lubricant, Personal

Bio-Tech Lubricants Ltd

The following data is part of a premarket notification filed by Bio-tech Lubricants Ltd with the FDA for Ah!yes Ob Coco Personal Lubricant.

Pre-market Notification Details

Device IDK191411
510k NumberK191411
Device Name:Ah!Yes Ob Coco Personal Lubricant
ClassificationLubricant, Personal
Applicant Bio-Tech Lubricants Ltd C/O Epsilon House, Enterprise Road, Southampton Science Park Southampton,  GB So16 7ns
ContactSarah Brooks
CorrespondentKaren Cornelius
Bio-Tech Lubricants Ltd C/O The Timber Barn, Selborne Road Greatham, Liss,  GB Gu33 6hg
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
510k Review PanelObstetrics/Gynecology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-28
Decision Date2020-02-06

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