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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K851936
Device Name STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
Applicant
Staar Surgical Co.
1911 Walker Ave.
Monrovia,  CA  91016
Applicant Contact CALLAHAN
Correspondent
Staar Surgical Co.
1911 Walker Ave.
Monrovia,  CA  91016
Correspondent Contact CALLAHAN
Regulation Number886.4150
Classification Product Code
HQE  
Date Received05/06/1985
Decision Date 08/20/1985
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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