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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 K011234
Device Name BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L
Applicant
American Biocurve, Inc.
623 Glacier Dr.
Grand Junction,  CO  81503
Applicant Contact MARTIN DALSING
Correspondent
American Biocurve, Inc.
623 Glacier Dr.
Grand Junction,  CO  81503
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received04/23/2001
Decision Date 06/13/2001
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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