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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, eye sphere
510(k) Number K021643
Device Name HA ORBITAL IMPLANT
Applicant
LABORATOIRE VILLANOVA
RESIDENCE BLUE MARINE
65 RUE LEON GARET
LE TOUQUET,  FR F62520
Applicant Contact ISABELLE DRUBAIX
Correspondent
LABORATOIRE VILLANOVA
RESIDENCE BLUE MARINE
65 RUE LEON GARET
LE TOUQUET,  FR F62520
Correspondent Contact ISABELLE DRUBAIX
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received05/20/2002
Decision Date 12/13/2002
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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