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510(k) K023688

Device
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
Applicant
LEMAITRE VASCULAR, INC.
510(k) number
K023688
Product code
GAF  
Decision
Substantially Equivalent (SESE)
Decision date
2003-01-30
Date received
2002-11-01
Regulation
878.4800
Classification name
Spatula, 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
JAMES ASHBY
Address
26 Ray Ave. Burlington MA US 01803 01803

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935357SNAP RECIPROCATING SAWSurgiquip, Inc.1994-01-28
K890374ABDOMINAL SPATULAKinetic Medical Products1989-02-03
K882793PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINEPmt Corp.1988-07-18
K822108CEMENT-PICKBio-Blitz, Inc.1982-08-11

Legacy Summary#

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FDA Review#

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