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510(k) K863635

Device
UPDATED STERILE ENDOTRACHEAL BRUSHES
Applicant
BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES
510(k) number
K863635
Product code
EPE  
Decision
Substantially Equivalent (SESE)
Decision date
1986-11-03
Date received
1986-09-17
Regulation
868.5795
Classification name
Brush, Cleaning, Tracheal Tube
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
NORMAN J HUFF
Address
615 Front St. Toledo OH US 43605 43605

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EPE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862563TRACHEOSTOMY CLEANSING SOLUTIONClinipad Corp.1986-07-15

Legacy Summary#

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FDA Review#

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