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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 Valve
510(k) Number K905129
Device Name BAERVELDT GLAUCOMA IMPLANT
Applicant
WRIGHT MEDICAL CORP.
P.O. BOX 800
PEAPACK,  NJ  07977
Applicant Contact RONALD J GARUTTI
Correspondent
WRIGHT MEDICAL CORP.
P.O. BOX 800
PEAPACK,  NJ  07977
Correspondent Contact RONALD J GARUTTI
Regulation Number886.3920
Classification Product Code
KYF  
Date Received11/14/1990
Decision Date 02/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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