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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K875197
Device Name OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE
Applicant
Pro-Optics, Inc.
C/O Hoogendoorn Talbot, Davids
122 S. Michigan Ave.
Chicago,  IL  60603
Applicant Contact JAMES DAVIDS
Correspondent
Pro-Optics, Inc.
C/O Hoogendoorn Talbot, Davids
122 S. Michigan Ave.
Chicago,  IL  60603
Correspondent Contact JAMES DAVIDS
Regulation Number886.5928
Classification Product Code
LRX  
Date Received12/17/1987
Decision Date 02/09/1988
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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