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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photokeratoscope
510(k) Number K893968
Device Name VKG 2000 VIDEO KERATOMETER
Applicant
Technitex, Inc.
11211 Richmond Ave., Suite
103
Houston,  TX  77082
Applicant Contact RONALD SPAIN
Correspondent
Technitex, Inc.
11211 Richmond Ave., Suite
103
Houston,  TX  77082
Correspondent Contact RONALD SPAIN
Regulation Number886.1350
Classification Product Code
HJA  
Date Received06/02/1989
Decision Date 09/11/1989
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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