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510(k) K981833

Device
SILIMED NASAL L SHAPED IMPLANT
Applicant
SILIMED, LLC.
510(k) number
K981833
Product code
FZE  
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-26
Date received
1998-05-26
Regulation
878.3680
Classification name
Prosthesis, Nose, Internal
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
E.J. Smith
Address
P.O. Box 4341 Crofton MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FZE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.2024-12-12
K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.2016-12-01
K090803HANSON MEDICAL FACIAL IMPLANTSHanson Medical, Inc.2010-06-30
K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)Nobel Biocare AB2009-06-02
K071018MONARCH NASAL IMPLANTHanson Medical, Inc.2007-05-25
K041690MONARCH NASAL IMPLANTHanson Medical, Inc.2005-02-11
K021418AART NASAL IMPLANTAesthetic and Reconstructive Technologies, Inc.2002-07-02
K992242PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTSPillar Surgical, Inc.1999-11-22
K983755NASAL DORSAL SERIESSurgical Technology Laboratories, Inc.1998-11-20
K982753SEARE BIOMEDICAL NASAL IMPLANTSSeare Biomedical Corp.1998-09-30
K973573DURALASTIC ANATOMICAL NASAL IMPLANTSHanson Medical, Inc.1997-11-13
K971481DURALASTIC ANATOMICAL NASAL IMPLANTSAllied Biomedical Corp.1997-07-18
K962824IMPLANTECH JEJ PERI-PYRIFORM IMPLANTImplantech Associates, Inc.1996-10-03
K961124THE NAUTILUSRand Scientific Corp.1996-04-19
K952709PROTHESIS, CHIN, INTERNALSpirit Ridge Technologies1995-08-28

Legacy Summary#

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FDA Review#

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