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510(k) K813589

Device
SHARTPOINT EYED NEEDLES
Applicant
S. JACKSON, INC.
510(k) number
K813589
Product code
GDL  
Decision
Substantially Equivalent (SESE)
Decision date
1982-01-18
Date received
1981-12-28
Regulation
878.4800
Classification name
Needle, Suturing, Reusable
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881394NON-STERILE SUTURE NEEDLESChina National Medicines C/O Havel'S1988-04-08
K85178125-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLESArtiberia1985-06-20
K85178225-450 TO 25-540 VARIOUS SUTURE FORCEPSArtiberia1985-06-20
K812566UNIVERSAL SUTURE PASSEROrtho Pared Instruments, Inc.1981-11-10

Legacy Summary#

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FDA Review#

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