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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K161322
Device Name CT CoPilot
Applicant
ZEPMED, LLC.
2465 Avenida de La Playa
La Jolla,  CA  92037
Applicant Contact Douglas J. Bates
Correspondent
MONROE MEDICAL DEVICE CONSULTING, LLC
319 Shilling Dr
Somerset,  NJ  08873
Correspondent Contact James W. Monroe
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/11/2016
Decision Date 12/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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