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510(k) K946293

Device
MILL-ROSE SCOPE CLEANING BRUSH
Applicant
MILL-ROSE LABORATORY
510(k) number
K946293
Product code
MNL  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-16
Date received
1994-12-27
Regulation
876.1500
Classification name
Accessories, Cleaning Brushes, For Endoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ALAN C POJE
Address
7310 Corporate Blvd. Mentor OH US 44060 44060

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
K892218ENDO-SPONGEEndovations1989-05-31
K874239CLEANING BRUSHEndovations1987-12-29

Legacy Summary#

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FDA Review#

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