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510(k) K923487

Device
BAL CATH
Applicant
BALLARD MEDICAL PRODUCTS
510(k) number
K923487
Product code
KTR  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1993-07-30
Date received
1992-07-15
Regulation
874.4680
Classification name
Tube, Aspirating, Bronchoscope, Rigid
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHAMBERLAIN, JR
Address
12050 Lone Peak Pkwy. Draper UT US 84020 84020

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KTR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K822255RIGID SUCTION TIPSKelleher Corp.1982-08-25
K820572ARGYLE DELEE SUCTION CATHETER W/MUCOUSSherwood Medical Co.1982-04-09
K791327ARGYLE TAUSSIG CULTURE CATHETERSherwood Medical Co.1979-08-22

Legacy Summary#

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FDA Review#

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