Pulse H20h!

Lubricant, Personal

TOASTER LABS, INC

The following data is part of a premarket notification filed by Toaster Labs, Inc with the FDA for Pulse H20h!.

Pre-market Notification Details

Device IDK152628
510k NumberK152628
Device Name:Pulse H20h!
ClassificationLubricant, Personal
Applicant TOASTER LABS, INC 2212 QUEEN ANNE AVENUE NORTH, #269 Seattle,  WA  98109
ContactAmy C. Buckalter
CorrespondentAmy C. Buckalter
TOASTER LABS, INC 2212 QUEEN ANNE AVENUE NORTH, #269 Seattle,  WA  98109
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-15
Decision Date2016-07-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00867003000204 K152628 000

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