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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 K090432
Device Name HEMORPEX SYSTEM
Applicant
ANGIOLOGICA B. M. SRL
4, VIA GIOVANNI XXIII
SAN MARTINO SICCOMARIO, PAVIA,  IT 27028
Applicant Contact ROBERTO MANCO
Correspondent
ANGIOLOGICA B. M. SRL
4, VIA GIOVANNI XXIII
SAN MARTINO SICCOMARIO, PAVIA,  IT 27028
Correspondent Contact ROBERTO MANCO
Regulation Number876.1500
Classification Product Code
FER  
Date Received02/19/2009
Decision Date 05/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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