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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Battery-Powered
510(k) Number K882902
Device Name QRK 100, QUALITATIVE RING KERATOSCOPE
Applicant
Technitex, Inc.
11211 Richmond Ave., Suite
103
Houston,  TX  77082
Applicant Contact RICHARD K SNOOK
Correspondent
Technitex, Inc.
11211 Richmond Ave., Suite
103
Houston,  TX  77082
Correspondent Contact RICHARD K SNOOK
Regulation Number886.1350
Classification Product Code
HLR  
Date Received07/12/1988
Decision Date 08/04/1988
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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