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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 K020193
Device Name OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
Applicant
Cl Mcintosh
12300 Twinbrook Pkwy. Suite 230
Rockville,  MD  20852
Applicant Contact RICHARD E LIPPMAN
Correspondent
Cl Mcintosh
12300 Twinbrook Pkwy. Suite 230
Rockville,  MD  20852
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.5925
Classification Product Code
LPL  
Date Received01/18/2002
Decision Date 02/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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