SILIMED MALAR IMPLANT

Implant, Malar

SILIMED, LLC.

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

Pre-market Notification Details

Device IDK981835
510k NumberK981835
Device Name:SILIMED MALAR IMPLANT
ClassificationImplant, Malar
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 CodeLZK  
CFR Regulation Number878.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-26
Decision Date1998-07-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812790023349 K981835 000
00812790023332 K981835 000
00812790023325 K981835 000
00812790023318 K981835 000
00812790023301 K981835 000
00812790023295 K981835 000

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