FDA.reportPublic FDA data

510(k) K820771

Device
MICROBIOLOGY SPECIMEN BRUSH
Applicant
MILL-ROSE LABORATORY
510(k) number
K820771
Product code
BTG  
Decision
Substantially Equivalent (SESE)
Decision date
1982-05-03
Date received
1982-03-23
Regulation
874.4680
Classification name
Brush, Biopsy, Bronchoscope (non-rigid)
Medical specialty
Ear Nose & Throat
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BTG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251279Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation2025-06-12
K182927Pulmonary Cytology BrushHobbs Medical, Inc.2020-02-07
K190293Single Use Cytology Brush BC-205DOlympus Medical Systems Corp.2019-08-02
K130357SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSHCovidien, LLC2013-11-06
K780872CYTOLOGY BRUSHCooperVision, Inc.1978-09-07

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases