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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
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