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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K853412
Device Name WAVE GATE
Applicant
Wolfline Corp.
5577 Honors Dr.
San Diego,  CA  92112
Applicant Contact ANN WOLF
Correspondent
Wolfline Corp.
5577 Honors Dr.
San Diego,  CA  92112
Correspondent Contact ANN WOLF
Regulation Number882.1890
Classification Product Code
GWE  
Date Received08/13/1985
Decision Date 10/28/1985
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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