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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K952165
Device Name TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS
Applicant
Rand Scientific Corp.
4135 Northgate Blvd. Suite 9
Sacramento,  CA  95834
Applicant Contact DUANE TRACY
Correspondent
Rand Scientific Corp.
4135 Northgate Blvd. Suite 9
Sacramento,  CA  95834
Correspondent Contact DUANE TRACY
Regulation Number886.5916
Classification Product Code
HQD  
Date Received04/03/1995
Decision Date 06/30/1995
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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