SILIMED TISSUE EXPANDER

Expander, Skin, Inflatable

SILIMED, LLC.

The following data is part of a premarket notification filed by Silimed, Llc. with the FDA for Silimed Tissue Expander.

Pre-market Notification Details

Device IDK981852
510k NumberK981852
Device Name:SILIMED TISSUE EXPANDER
ClassificationExpander, Skin, Inflatable
Applicant SILIMED, LLC. P.O BOX 4341 Crofton,  MD  21114
ContactE.j. Smith
CorrespondentE.j. Smith
SILIMED, LLC. P.O BOX 4341 Crofton,  MD  21114
Product CodeLCJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-26
Decision Date1998-08-05

NIH GUDID Devices

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