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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Schirmer
510(k) Number K911734
Device Name TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
Applicant
Northland Cataract & Eye Care Clinic
5500 N. Oak, Suite 202
Kansas City,  MO  64118
Applicant Contact JERRY W COOK
Correspondent
Northland Cataract & Eye Care Clinic
5500 N. Oak, Suite 202
Kansas City,  MO  64118
Correspondent Contact JERRY W COOK
Regulation Number886.1800
Classification Product Code
KYD  
Date Received04/17/1991
Decision Date 11/07/1991
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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