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510(k) K862563

Device
TRACHEOSTOMY CLEANSING SOLUTION
Applicant
CLINIPAD CORP.
510(k) number
K862563
Product code
EPE  
Decision
Substantially Equivalent (SESE)
Decision date
1986-07-15
Date received
1986-07-03
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
SIDNEY FINKELSTEIN
Address
66 High St. P.O. Box 387 Guilford CT US 06437 06437

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
K863635UPDATED STERILE ENDOTRACHEAL BRUSHESBiological & Environmental Control Laboratories1986-11-03

Legacy Summary#

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FDA Review#

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