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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K032412
Device Name RE-USEABLE MICROSTAAR INJECTOR, MSI-S
Applicant
Staar Surgical Co.
1911 Walker Ave.
Monrovia,  CA  91016
Applicant Contact JASON K LYON
Correspondent
Staar Surgical Co.
1911 Walker Ave.
Monrovia,  CA  91016
Correspondent Contact JASON K LYON
Regulation Number886.4300
Classification Product Code
KYB  
Date Received08/05/2003
Decision Date 06/10/2004
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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