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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 K051035
Device Name SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS
Applicant
SYNERGEYES
15825 SHADY GROVE ROAD
SUITE 30
ROCKVILLE,  MD  20850
Applicant Contact RICHARD E LIPPMAN
Correspondent
SYNERGEYES
15825 SHADY GROVE ROAD
SUITE 30
ROCKVILLE,  MD  20850
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.5916
Classification Product Code
HQD  
Date Received04/22/2005
Decision Date 09/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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