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510(k) K952737

Device
CALVITRON HAIR TRANSPLANT SYSTEM
Applicant
MEDICAMAT S.A.
510(k) number
K952737
Product code
GAH  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-03
Date received
1995-06-15
Regulation
878.4800
Classification name
Stylet, Surgical, General & Plastic Surgery
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANDREW S KRULWICH
Address
1776 K St. NW Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110355VENX REVOLUTIONVenx, LLC2011-04-22
K000932ARACHNOPHLEBECTOMY NEEDLEAdvanced Medical Products, Inc.2000-05-17
K970306MARKMAN TEMPLATE SYSTEMBarry Markman, M.D.1997-11-20
K972918RAPID FIRE HAIR IMPLANTER CAROUSELApex Medical Products, LLC1997-10-27
K972521NAVIGATOR (STYLET) 2006Sil-Med Corp.1997-10-01
K770970HAIR TRANSPLANT PUNCH, MULTIPLHPadgett Instruments, Inc.1977-10-27

Legacy Summary#

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FDA Review#

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