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510(k) K861877

Device
BYRON WORD BARTHOLIAN GLAND CATHETER
Applicant
BYRON MEDICAL
510(k) number
K861877
Product code
GBA  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-30
Date received
1986-05-15
Regulation
878.4200
Classification name
Catheter, Balloon Type
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FRED CHAPEL
Address
3280 E. Hemisphere Loop Suite 100 Tucson AZ US 85706 85706

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K802025BALLOON RETENTION CHEST CATHETERLoseff Medical Designers, Ltd.1980-09-26
K790444ELECATH MULTI-PURPOSE ARTERIAL SURGERElectro-Catheter Corp.1979-06-11
K781772CATHETER, TRANSLUMINAL BALLOONMedi-Tech, Inc.1979-03-06
K781665TUBE, LEATHERMAN/IMBRUCENational Catheter Co. Div. Mallinckrodt1978-12-15

Legacy Summary#

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FDA Review#

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