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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrolysis, Battery-Powered, Ophthalmic
510(k) Number K903666
Device Name OPHTHASONIC A/P III
Applicant
Teknar, Inc.
267 Wolfner Dr.
Fenton,  MO  63026
Applicant Contact CHUCK KUHLMANN
Correspondent
Teknar, Inc.
267 Wolfner Dr.
Fenton,  MO  63026
Correspondent Contact CHUCK KUHLMANN
Regulation Number886.4250
Classification Product Code
HPY  
Date Received08/14/1990
Decision Date 11/19/1990
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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