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510(k) K790856

Device
PROCTOSCOPE #501
Applicant
C. INTL.
510(k) number
K790856
Product code
GCF  
Decision
Substantially Equivalent (SESE)
Decision date
1979-05-29
Date received
1979-05-04
Regulation
876.1500
Classification name
Proctoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
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 GCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945209PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTSKARL STORZ Endoscopy-America, Inc.1995-03-06

Legacy Summary#

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FDA Review#

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