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510(k) K851781

Device
25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES
Applicant
ARTIBERIA
510(k) number
K851781
Product code
GDL  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-20
Date received
1985-04-25
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#

Contact
GIL M SANCHEZ
Address
4518 Los Ranchitos San Antonio TX US 78233 78233

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
K85178225-450 TO 25-540 VARIOUS SUTURE FORCEPSArtiberia1985-06-20
K813589SHARTPOINT EYED NEEDLESS. Jackson, Inc.1982-01-18
K812566UNIVERSAL SUTURE PASSEROrtho Pared Instruments, Inc.1981-11-10

Legacy Summary#

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FDA Review#

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