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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 K183038
Device Name Corin Optimized Positioning System (OPS) Plan
Applicant
Corin USA
12750 Citrus Park Lane, Suite 120
Tampa,  FL  33625
Applicant Contact Lucinda Gerber
Correspondent
Corin (Australia)
17 Bridge Street
Pymble,  AU 2073
Correspondent Contact Martina Cecconi
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
LZO   MEH  
Date Received11/01/2018
Decision Date 11/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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