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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Weights, Eyelid, External
510(k) Number K150986
Device Name Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
Applicant
MEDDEV CORPORATION
730 NORTH PASTORIA AVE
SUNNYVALE,  CA  94085
Applicant Contact PATRICK GREY
Correspondent
MEDDEV CORPORATION
730 N. Pastoria Ave
Sunnyvale,  CA  94085
Correspondent Contact Eileen Ho
Regulation Number886.5700
Classification Product Code
MML  
Date Received04/14/2015
Decision Date 08/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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