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510(k) K862696

Device
TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
Applicant
DOWNS SURGICAL LTD.
510(k) number
K862696
Product code
HBT  
Decision
Substantially Equivalent (SESE)
Decision date
1986-07-30
Date received
1986-07-15
Regulation
878.4800
Classification name
Applier, Hemostatic Clip
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN FORSTER
Address
42 Industrial Way Wilmington MA US 01887 01887

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HBT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K924929REFLEX(R) ECARichard-Allan Medical1993-07-21
K896262TITANIUM LIGATING CLIPSRichard-Allan Medical Ind., Inc.1990-01-02
K800318DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLIEdward Weck, Inc.1980-03-10

Legacy Summary#

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FDA Review#

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