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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 K932258
Device Name OPTICOM M600
Applicant
Clement Clarke, Inc.
3128 E. 17th.Ave. Unit D
Columbus,  OH  43219
Applicant Contact THOMAS LEHMAN
Correspondent
Clement Clarke, Inc.
3128 E. 17th.Ave. Unit D
Columbus,  OH  43219
Correspondent Contact THOMAS LEHMAN
Regulation Number886.1605
Classification Product Code
HPT  
Date Received05/10/1993
Decision Date 07/25/1994
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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