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510(k) K950924

Device
ASLAN KNOT PUSHER
Applicant
ASLAN MEDICAL TECHNOLOGIES, LTD.
510(k) number
K950924
Product code
FDE  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-14
Date received
1995-03-01
Regulation
876.1500
Classification name
Laparoscopy Kit
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THOMAS J HOOGEBOOM
Address
6376 Quail Run Dr. Kalamazoo MI US 49009 49009

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FDE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955717ENDOSCOPE INTRODUCER KITMitsubishi Cable America, Inc.1996-04-18
K942677GEENEN/ZEBRA GUIDELINESBoston Scientific Corp1994-07-21
K912443CANDELA INTRODUCER SHEATH SYSTEMCandela Laser Corp.1991-08-16

Legacy Summary#

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FDA Review#

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