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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 K003042
Device Name V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT
Applicant
JOE B. GOLDBERG, O.D.
5500-B DAWSON RD.
VIRGINIA BEACH,  VA  23451
Applicant Contact JOE B GOLDBERG
Correspondent
JOE B. GOLDBERG, O.D.
5500-B DAWSON RD.
VIRGINIA BEACH,  VA  23451
Correspondent Contact JOE B GOLDBERG
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/29/2000
Decision Date 01/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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