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510(k) K862717

Device
HAND MIRROR (ENDOSCOPE)
Applicant
SIMPSON/BASYE, INC.
510(k) number
K862717
Product code
GCO  
Decision
Substantially Equivalent (SESE)
Decision date
1986-07-30
Date received
1986-07-17
Regulation
876.1500
Classification name
Endoscope, Mirror
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT BASYE
Address
430 Ayre St. Wilmington DE US 19804 19804

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862838CYTOTECH HSV IGG ENZYME IMMUNOASSAYCytotech, Inc.1986-12-09
K790340DELTA-ROLJohnson & Johnson Professionals, Inc.1979-04-12

Legacy Summary#

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FDA Review#

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