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510(k) K851452

Device
VALTRAC PURSESTING DEVICE
Applicant
DAVIS & GECK, INC.
510(k) number
K851452
Product code
HCF  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-12
Date received
1985-04-11
Regulation
878.4800
Classification name
Instrument, Ligature Passing And Knot Tying
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PELLETIER
Address
American Cynamid Company One Casper St. Danbury CT US 06810 06810

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150882Edwards Suture Fastening SystemEdwards Lifesciences, LLC2015-06-16
K931379MICROVASIVE INSURG LAPTIE SUTURE LIGATORBoston Scientific Corp1993-07-13
K841617STROVER HOOKPlastafil, Inc.1984-08-27
K790577HEMORRHOIDAL LIGATORJ. Sklar Mfg. Co., Inc.1979-04-23

Legacy Summary#

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FDA Review#

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