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510(k) K241253

Device
Medicon Epiplating System
Applicant
Cmf Medicon Surgical, Inc.
510(k) number
K241253
Product code
FZE
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-12
Date received
2024-05-03
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
Matthias Alber
Address
11200 St. Johns Industrial Pkwy. N. Suite 1 Jacksonville FL US 32246 32246

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FZE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K981833SILIMED NASAL L SHAPED IMPLANTSilimed, LLC1998-06-26
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