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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 (Other Material) - Daily
510(k) Number K081034
Device Name SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS
Applicant
Synergeyes, Inc.
15825 Shady Grove Rd.Suite 30
Rockville,  MD  20850
Applicant Contact RICHARD E LIPPMAN
Correspondent
Synergeyes, Inc.
15825 Shady Grove Rd.Suite 30
Rockville,  MD  20850
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.5916
Classification Product Code
HQD  
Date Received04/11/2008
Decision Date 05/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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