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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anoscope And Accessories
510(k) Number K011825
Device Name RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE
Applicant
Sightline Technologies , Ltd.
Advanced Technology Center
Matam, Haifa,  IL 31905
Applicant Contact SIMCHA EDELL
Correspondent
Sightline Technologies , Ltd.
Advanced Technology Center
Matam, Haifa,  IL 31905
Correspondent Contact SIMCHA EDELL
Regulation Number876.1500
Classification Product Code
FER  
Subsequent Product Code
GCF  
Date Received06/11/2001
Decision Date 07/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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