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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 K950530
Device Name PRO-TEC-CASE
Applicant
Hyman, Phelps & McNamara, P.C.
700 13th St. NW Suite 1200
Washington Dc,  DC  20005
Applicant Contact A. WES SIEGNER, JR.
Correspondent
Hyman, Phelps & McNamara, P.C.
700 13th St. NW Suite 1200
Washington Dc,  DC  20005
Correspondent Contact A. WES SIEGNER, JR.
Regulation Number886.5928
Classification Product Code
LRX  
Date Received02/07/1995
Decision Date 04/07/1995
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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