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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 K954746
Device Name PHACO TIP
Applicant
U.S. Iol, Inc.
9327 Blackley St.
Temple City,  CA  91789
Applicant Contact GLEN A DUNKI-JACOBS
Correspondent
U.S. Iol, Inc.
9327 Blackley St.
Temple City,  CA  91789
Correspondent Contact GLEN A DUNKI-JACOBS
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/16/1995
Decision Date 01/11/1996
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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