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510(k) K863034

Device
SHARPOINT STAINLESS STEEL SUTURE
Applicant
CHATHAMBOROUGH RESEARCH GROUP, INC.
510(k) number
K863034
Product code
GAO  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-30
Date received
1986-08-11
Regulation
878.4495
Classification name
Suture, Nonabsorbable
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TIM HUBBARD
Address
105 W. St. P.O. Box Drawer 929 Pittsboro NC US 27312 27312

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932513LABELING FOR MYO/WIRE II STERNOTOMY SUTURESAlto Development Corp.1994-01-07
K872532AUTO SUTURE STAINLESS STEEL SUTURES*United States Surgical, A Division of Tyco Healthc1987-08-05
K802248DISARP ORIGINALUnoplast A/S1980-09-26

Legacy Summary#

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FDA Review#

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