SILIMED PECTORAL IMPLANT

Elastomer, Silicone Block

SILIMED, INC.

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

Pre-market Notification Details

Device IDK042054
510k NumberK042054
Device Name:SILIMED PECTORAL IMPLANT
ClassificationElastomer, Silicone Block
Applicant SILIMED, INC. PO BOX 4341 Crofton,  MD  21114
ContactE.j. Smith
CorrespondentE.j. Smith
SILIMED, INC. PO BOX 4341 Crofton,  MD  21114
Product CodeMIB  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-30
Decision Date2005-02-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812790023189 K042054 000
00812790023172 K042054 000
00812790023165 K042054 000
00812790023158 K042054 000
00812790023141 K042054 000
00812790023134 K042054 000

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