Unger Quad Injector

Expander, Skin, Inflatable

STRADIS HEALTHCARE

The following data is part of a premarket notification filed by Stradis Healthcare with the FDA for Unger Quad Injector.

Pre-market Notification Details

Device IDK161483
510k NumberK161483
Device Name:Unger Quad Injector
ClassificationExpander, Skin, Inflatable
Applicant STRADIS HEALTHCARE 805 MARATHON PKWY SUITE 100 Lawrenceville,  GA  30046
ContactJoseph Trznadel
CorrespondentH. Carl Jenkins
Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff,  IL  60044
Product CodeLCJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-31
Decision Date2016-10-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888628043619 K161483 000
10888628043602 K161483 000

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