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510(k) K973729

Device
POWERFLEX PEC IMPLANT
Applicant
HANSON MEDICAL, INC.
510(k) number
K973729
Product code
MIC  
Decision
Substantially Equivalent (SESE)
Decision date
1997-12-24
Date received
1997-09-30
Regulation
874.3620
Classification name
Implant, Muscle, Pectoralis
Medical specialty
Ear Nose & Throat
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ERIK HANSON
Address
P.O. Box 1160 Kingston WA US 98346 98346

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MIC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021337AART PECTORALIS IMPLANTAesthetic and Reconstructive Technologies, Inc.2002-07-03
K002633SILMAX PECTORAL IMPLANTPillar Surgical, Inc.2000-11-21
K982762SEARE BIOMEDICAL PECTORALIS IMPLANTSeare Biomedical Corp.1998-09-30
K983043SEARE BIOMEDICAL SILICONE BLOCKSeare Biomedical Corp.1998-09-30
K961072PEC IMPLANTRand Scientific Corp.1996-04-19
K944163SPECTRUM DISIGNS PECTORAL IMPLANTSpectrum Designs, Inc.1994-11-07
K913768PEC IMPLANTApplied Biomaterial Technologies1992-02-03

Legacy Summary#

summary

FDA Review#

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