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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name preamplifier, battery-powered, ophthalmic
510(k) Number K900098
Device Name MONOPOLAR NEEDLE ELECTRODE
Applicant
OCULINUM, INC.
901 GRAYSON ST.
BERKELEY,  CA  94710
Applicant Contact SCOTT, M.D.
Correspondent
OCULINUM, INC.
901 GRAYSON ST.
BERKELEY,  CA  94710
Correspondent Contact SCOTT, M.D.
Regulation Number886.1640
Classification Product Code
HLW  
Date Received01/08/1990
Decision Date 02/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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