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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 K011740
Device Name CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
Applicant
Meddev Corp.
730 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact SUZANNA BRICK
Correspondent
Meddev Corp.
730 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact SUZANNA BRICK
Regulation Number886.5700
Classification Product Code
MML  
Date Received06/05/2001
Decision Date 07/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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