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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K120289
Device Name PEERSCOPE SYSTEM
Applicant
PEERMEDICAL
6 SIRENI
HAIFA,  IL 32972
Applicant Contact DAN LAOR
Correspondent
PEERMEDICAL
6 SIRENI
HAIFA,  IL 32972
Correspondent Contact DAN LAOR
Regulation Number876.1500
Classification Product Code
FDF  
Date Received01/31/2012
Decision Date 09/28/2012
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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