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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
Original Applicant
PEERMEDICAL
6 sireni
haifa,  IL 32972
Original 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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