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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
510(k) Number K871245
Device Name LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1
Applicant
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618 -1903
Applicant Contact DEBORAH HELENIHI
Correspondent
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618 -1903
Correspondent Contact DEBORAH HELENIHI
Regulation Number886.4390
Classification Product Code
LQJ  
Date Received03/27/1987
Decision Date 05/07/1987
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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