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510(k) K896998

Device
ATRAUCLIP (TANTALUM HEMOSTATIC CLIP)
Applicant
S.P.K. TECHNOLOGY, INC.
510(k) number
K896998
Product code
MCH  
Decision
Substantially Equivalent (SESE)
Decision date
1990-06-01
Date received
1989-12-12
Regulation
878.4300
Classification name
Clip, Hemostatic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN J MALLOY
Address
321 Regatta Way Seal Beach CA US 90740 90740

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MCH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040148RESOLUTION HEMOSTASIS CLIPPING DEVICEBoston Scientific Corp2004-04-22
K972745TITANIUM HEMOSTATIC CLIPEisner USA, Inc.1997-10-21

Legacy Summary#

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FDA Review#

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