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510(k) K011825

Device
RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE
Applicant
Sightline Technologies , Ltd.
510(k) number
K011825
Product code
FER
Decision
Substantially Equivalent (SESE)
Decision date
2001-07-11
Date received
2001-06-11
Regulation
876.1500
Classification name
Anoscope And Accessories
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SIMCHA EDELL
Address
Advanced Technology Center Matam, Haifa IL 31905 31905

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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