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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscope, accessories, image post-processing for color enhancement
510(k) Number K122470
Device Name PENTAX EPK-I5010 VIDEO PROCESSOR
Original Applicant
PENTAX MEDICAL
3 paragon drive
montvale,  NJ  07645
Original Contact krishna govindarajan
Regulation Number876.1500
Classification Product Code
PEA  
Date Received08/13/2012
Decision Date 04/10/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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