Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant

Lubricant, Personal

Package Solutions LLC

The following data is part of a premarket notification filed by Package Solutions Llc with the FDA for Swiss Navy Premium Silicone Lubricant;swiss Navy Premium Water Based Lubricant;swiss Navy Premium All Natural Lubricant.

Pre-market Notification Details

Device IDK150153
510k NumberK150153
Device Name:Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant
ClassificationLubricant, Personal
Applicant Package Solutions LLC 2131 Blount Road Pompano Beach,  FL  33069
ContactJack Scalisi
CorrespondentJack Scalisi
Package Solutions LLC 2131 Blount Road Pompano Beach,  FL  33069
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-23
Decision Date2015-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00760236441083 K150153 000
00760236441076 K150153 000
00760236441045 K150153 000

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