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510(k) K924929

Device
REFLEX(R) ECA
Applicant
RICHARD-ALLAN MEDICAL
510(k) number
K924929
Product code
HBT  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-21
Date received
1992-09-30
Regulation
878.4800
Classification name
Applier, Hemostatic Clip
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JULIE POWELL
Address
8850m89, Box 351 Richland MI US 49083 49083

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HBT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K896262TITANIUM LIGATING CLIPSRichard-Allan Medical Ind., Inc.1990-01-02
K862696TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEPDowns Surgical , Ltd.1986-07-30
K800318DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLIEdward Weck, Inc.1980-03-10

Legacy Summary#

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FDA Review#

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