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510(k) K982763

Device
SEARE BIOMEDICAL MALAR IMPLANTS
Applicant
Seare Biomedical Corp.
510(k) number
K982763
Product code
LZK
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-30
Date received
1998-08-06
Regulation
878.3550
Classification name
Implant, Malar
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
WILLIAM JOHN SEARE, JR.
Address
3190 Chula Vista Cir. Salt Lake City UT US 84121 84121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021419AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.2002-07-02
K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)Implantech Associates, Inc.2000-11-24
K992240PILLAR MALAR IMPLANTPillar Surgical, Inc.1999-11-22
K983756SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.1998-11-20
K981835SILIMED MALAR IMPLANTSilimed, LLC1998-07-09
K980141SPECTRUM DESIGNS PROJECTION MALAR IMPLANTSpectrum Designs, Inc.1998-03-03
K980139SPECTRUM DESIGNS PROFILE MALAR IMPLANTSpectrum Designs, Inc.1998-03-03
K980140SPECTRUM DESIGNS MEDIAL MALAR IMPLANTSpectrum Designs, Inc.1998-03-03
K973502IMPLANTECH CONFORM BINDER SUBMALAR IMPLANTImplantech Associates, Inc.1997-11-07
K973574DURALASTIC ANATOMICAL MALAR IMPLANTHanson Medical, Inc.1997-10-24
K971479DURALASTIC ANATOMICAL MALAR IMPLANTSAllied Biomedical Corp.1997-07-18
K970400BONE SOURCE HYDROXYAPATITEOrthofix, Inc.1997-05-02
K964443SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.1996-12-20
K962261IMPLANTECH WM NASAL-LABIAL IMPLANTImplantech Associates, Inc.1996-08-19
K961511HAPSET HYDROXYLAPATITE BONE GRAFT PLASTERLifecore Biomedical, Inc.1996-06-28