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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perimeter, Automatic, Ac-Powered
510(k) Number K954037
Device Name FIELD TREND
Applicant
Synemed, Inc.
4562 E. Second St., Suite D
Benicia,  CA  94510
Applicant Contact NEAL COMPTON
Correspondent
Synemed, Inc.
4562 E. Second St., Suite D
Benicia,  CA  94510
Correspondent Contact NEAL COMPTON
Regulation Number886.1605
Classification Product Code
HPT  
Date Received08/28/1995
Decision Date 11/17/1995
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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