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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K863846
Device Name CONTAC CASE
Applicant
S. M. C. Medi-Tech Corp.
1931 N. Great Southwest Pkwy.
Grand Prairie,  TX  75050
Applicant Contact HENRY W JENRICKS
Correspondent
S. M. C. Medi-Tech Corp.
1931 N. Great Southwest Pkwy.
Grand Prairie,  TX  75050
Correspondent Contact HENRY W JENRICKS
Regulation Number886.5928
Classification Product Code
LPN  
Date Received10/01/1986
Decision Date 04/06/1987
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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