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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 K925828
Device Name MODIFIED SITE TXR SYSTEMS
Applicant
Site Microsurgical Systems, Inc.
135 Gibraltar Rd.
Horsham,  PA  19044
Applicant Contact JAMES K MCCRACKEN
Correspondent
Site Microsurgical Systems, Inc.
135 Gibraltar Rd.
Horsham,  PA  19044
Correspondent Contact JAMES K MCCRACKEN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received11/16/1992
Decision Date 02/16/1994
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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