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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 K113586
Device Name SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
Applicant
Synergeyes, Inc.
15825 SHADY GROVE ROAD
SUITE 30
ROCKVILLE,  MD  20850
Applicant Contact RICHARD E LIPPMAN
Correspondent
Synergeyes, Inc.
15825 SHADY GROVE ROAD
SUITE 30
ROCKVILLE,  MD  20850
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.5916
Classification Product Code
HQD  
Date Received12/05/2011
Decision Date 04/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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