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510(k) K972745

Device
TITANIUM HEMOSTATIC CLIP
Applicant
EISNER USA, INC.
510(k) number
K972745
Product code
MCH  
Decision
Substantially Equivalent (SESE)
Decision date
1997-10-21
Date received
1997-07-23
Regulation
878.4300
Classification name
Clip, Hemostatic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ELLEN HENVE-UNEPP
Address
15 Caswell Ln., Boatyard Sq. Plymouth MA US 02360 02360

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K896998ATRAUCLIP (TANTALUM HEMOSTATIC CLIP)S.P.K. Technology, Inc.1990-06-01

Legacy Summary#

summary

FDA Review#

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