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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, (Disposable)
510(k) Number K020389
Device Name BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
Applicant
Ocular Sciences
12300 Twinbrook Pkwy. Suite 230
Rockville,  MD  20852
Applicant Contact RICHARD E LIPPMAN
Correspondent
Ocular Sciences
12300 Twinbrook Pkwy. Suite 230
Rockville,  MD  20852
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received02/05/2002
Decision Date 06/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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