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510(k) K874239

Device
CLEANING BRUSH
Applicant
ENDOVATIONS
510(k) number
K874239
Product code
MNL  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-29
Date received
1987-10-16
Regulation
876.1500
Classification name
Accessories, Cleaning Brushes, For Endoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SUSAN P BJORKMAN
Address
895 Poplar Church Rd. Camp Hill PA US 17011 17011

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MNL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950689UCBCox Medical Ent., Inc.1995-03-06
K946293MILL-ROSE SCOPE CLEANING BRUSHMill-Rose Laboratory1995-02-16
K892218ENDO-SPONGEEndovations1989-05-31

Legacy Summary#

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FDA Review#

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