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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K942372
Device Name SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS
Applicant
Unilens Corp., USA
10431 72nd St. N.
P.O. Box 2530
Largo,  FL  34647
Applicant Contact JOSEPHA BRUNO
Correspondent
Unilens Corp., USA
10431 72nd St. N.
P.O. Box 2530
Largo,  FL  34647
Correspondent Contact JOSEPHA BRUNO
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/18/1994
Decision Date 07/07/1994
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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