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510(k) K800623

Device
JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE
Applicant
PILLING CO.
510(k) number
K800623
Product code
KCD  
Decision
Substantially Equivalent (SESE)
Decision date
1980-04-24
Date received
1980-03-19
Regulation
874.4420
Classification name
Bougie, Esophageal, Ent
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
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 KCD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K844169VOLUMATICGlaxo, Inc.1984-11-09
K822258ESOPHAGEAL BOUGIESKelleher Corp.1982-08-25

Legacy Summary#

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FDA Review#

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