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510(k) K884553

Device
STAMEY NEEDLE
Applicant
COOK OB/GYN
510(k) number
K884553
Product code
GEJ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-11-14
Date received
1988-10-31
Regulation
878.4800
Classification name
Carrier, Ligature
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MICHELLE YOUNG
Address
1100 W. Morgan St. P.O. Box 271 Spencer IN US 47460 47460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GEJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240185Cypris eXact Suture Placement DeviceCypris Medical2024-05-03
K900958GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MMSolos Endoscopy, Inc.1990-04-18
K900959GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATEDSolos Endoscopy, Inc.1990-04-18
K874342LIGATURE CARRIER/PACKER, HYDROXYLAPATITECox-Uphuff Intl.1987-11-13

Legacy Summary#

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FDA Review#

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