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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K182263
Device Name RetCam 3 ; RetCam Shuttle ; RetCam Portable
Applicant
Natus Medical Incorporated
1183 Quarry Lane, Suite A
Pleasanton,  CA  94566
Applicant Contact Brian R. Ackley
Correspondent
Natus Medical Incorporated
1183 Quarry Lane, Suite A
Pleasanton,  CA  94566
Correspondent Contact Brian R. Ackley
Regulation Number886.1120
Classification Product Code
HKI  
Date Received08/21/2018
Decision Date 09/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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