SuperSlyde Personal Lubricant

Lubricant, Personal

ICM Pharma Pte Ltd

The following data is part of a premarket notification filed by Icm Pharma Pte Ltd with the FDA for Superslyde Personal Lubricant.

Pre-market Notification Details

Device IDK172306
510k NumberK172306
Device Name:SuperSlyde Personal Lubricant
ClassificationLubricant, Personal
Applicant ICM Pharma Pte Ltd 26 Kallang Place #05-17 Singapore,  SG 339157
ContactDennis Fortich
CorrespondentMoturi Srinivasa Rao
ICM Pharma Pte Ltd 26 Kallang Place #05-17 Singapore,  SG 339157
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-31
Decision Date2018-04-19
Summary:summary

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