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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 K171847
Device Name Corin Optimized Positioning System (OPS™) Plan
Applicant
Corin U.S.A. Limited
12750 Citrus Park Ln.
Suite 120
Tampa,  FL  33625
Applicant Contact Kathy Trier
Correspondent
Corin U.S.A. Limited
12750 Citrus Park Ln.
Suite 120
Tampa,  FL  33625
Correspondent Contact Martina Cecconi
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
LZO   MEH  
Date Received06/21/2017
Decision Date 04/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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