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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K921163
Device Name REGALTECH MAXISCOPE
Applicant
Regaltech Pty. , Ltd.
12 Princes St.
Cottesloe 6011
Western Australia,  AU
Applicant Contact MAXIMILIAAN CUYPERS
Correspondent
Regaltech Pty. , Ltd.
12 Princes St.
Cottesloe 6011
Western Australia,  AU
Correspondent Contact MAXIMILIAAN CUYPERS
Regulation Number886.1570
Classification Product Code
HLI  
Date Received03/11/1992
Decision Date 10/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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