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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K030957
Device Name PERFECT CAPSULE
Applicant
Milvella Pty. , Ltd.
2 Delphinus
Irvine,  CA  92612
Applicant Contact JUDY F GORDON
Correspondent
Milvella Pty. , Ltd.
2 Delphinus
Irvine,  CA  92612
Correspondent Contact JUDY F GORDON
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/27/2003
Decision Date 08/20/2003
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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