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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K093785
Device Name MODULAR ENDOSCOPE
Applicant
SIALO TECHNOLOGY, LTD.
20 HATA'AS STR.,
SUITE 102
KFAR SABA,  IL 44425
Applicant Contact AHAVA STEIN/ EYAL OZERI
Correspondent
SIALO TECHNOLOGY, LTD.
20 HATA'AS STR.,
SUITE 102
KFAR SABA,  IL 44425
Correspondent Contact AHAVA STEIN/ EYAL OZERI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/09/2009
Decision Date 08/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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