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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 Management, Ophthalmic
510(k) Number K071299
Device Name IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
Applicant
Digital Healthcare, Ltd.
343 S. White St.
Wake Forest,  NC  27587
Applicant Contact GERRY SKEWS
Correspondent
Digital Healthcare, Ltd.
343 S. White St.
Wake Forest,  NC  27587
Correspondent Contact GERRY SKEWS
Regulation Number892.2050
Classification Product Code
NFJ  
Subsequent Product Codes
HKI   NFF   NFG  
Date Received05/09/2007
Decision Date 08/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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