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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pinwheel
510(k) Number K871167
Device Name SENSITESTER
Applicant
Dexin Pty. , Ltd.
221 High St.
Fremantle, 6160
Western Australia,  AU
Applicant Contact DR. S BAJADA
Correspondent
Dexin Pty. , Ltd.
221 High St.
Fremantle, 6160
Western Australia,  AU
Correspondent Contact DR. S BAJADA
Regulation Number882.1750
Classification Product Code
GWY  
Date Received03/24/1987
Decision Date 04/01/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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