Instylla Delivery Kit

Syringe, Piston

Instylla, Inc.

The following data is part of a premarket notification filed by Instylla, Inc. with the FDA for Instylla Delivery Kit.

Pre-market Notification Details

Device IDK202544
510k NumberK202544
Device Name:Instylla Delivery Kit
ClassificationSyringe, Piston
Applicant Instylla, Inc. 201 Burlington Rd, North Building Bedford,  MA  01730
ContactJennifer Greer
CorrespondentJennifer Greer
Instylla, Inc. 201 Burlington Rd, North Building Bedford,  MA  01730
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-02
Decision Date2021-01-07

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