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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 K854793
Device Name MONOPOLAR INJECTION NEEDLE ELECTRODE
Applicant
Oculinum, Inc.
P. O. Box 175
Mill Valley,  CA  94942
Applicant Contact SCOTT, M.D.
Correspondent
Oculinum, Inc.
P. O. Box 175
Mill Valley,  CA  94942
Correspondent Contact SCOTT, M.D.
Regulation Number886.1640
Classification Product Code
HLW  
Date Received12/05/1985
Decision Date 02/18/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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