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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 K955455
Device Name BAERVELT PARS PLANA GLAUCOMA IMPLANT
Applicant
Pharmacia Iovision, Inc.
P.O. Box 800
Peapack,  NJ  07977
Applicant Contact RONALD J GARUTTI
Correspondent
Pharmacia Iovision, Inc.
P.O. Box 800
Peapack,  NJ  07977
Correspondent Contact RONALD J GARUTTI
Regulation Number886.3920
Classification Product Code
KYF  
Date Received11/29/1995
Decision Date 02/18/1997
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
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