SILICONE GEL SHEETING

Elastomer, Silicone, For Scar Management

CUI CORP.

The following data is part of a premarket notification filed by Cui Corp. with the FDA for Silicone Gel Sheeting.

Pre-market Notification Details

Device IDK913140
510k NumberK913140
Device Name:SILICONE GEL SHEETING
ClassificationElastomer, Silicone, For Scar Management
Applicant CUI CORP. P.O. BOX 40288 Santa Barbara,  CA  93140
ContactEllen Duke
CorrespondentEllen Duke
CUI CORP. P.O. BOX 40288 Santa Barbara,  CA  93140
Product CodeMDA  
CFR Regulation Number878.4025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-16
Decision Date1991-09-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00768627007146 K913140 000
00768627007139 K913140 000
00768627007122 K913140 000
00768627007108 K913140 000
00768627007092 K913140 000
00768627007085 K913140 000
00768627007078 K913140 000

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