OFNat Lubricant (L15)

Lubricant, Personal

Suretex Limited

The following data is part of a premarket notification filed by Suretex Limited with the FDA for Ofnat Lubricant (l15).

Pre-market Notification Details

Device IDK221243
510k NumberK221243
Device Name:OFNat Lubricant (L15)
ClassificationLubricant, Personal
Applicant Suretex Limited 31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai, Amphur Phunphin,  TH 84130
ContactKC Nguyen
CorrespondentCarole C Carey
C3-Carey Consultants, LLC 9451 Ellsworth Court Fulton,  MD  20759
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-09-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
80070907101120 K221243 000
10070907001155 K221243 000
00070907001141 K221243 000
18859798100374 K221243 000
08859798100360 K221243 000
08859798100353 K221243 000
08859798100339 K221243 000

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