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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 K954600
Device Name MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
Applicant
Staar Surgical Co.
1911 Walker Ave.
Monrovia,  CA  91016
Applicant Contact DAVID S FERNQUIST
Correspondent
Staar Surgical Co.
1911 Walker Ave.
Monrovia,  CA  91016
Correspondent Contact DAVID S FERNQUIST
Regulation Number886.4300
Classification Product Code
KYB  
Date Received09/25/1995
Decision Date 12/21/1995
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
Recalls CDRH Recalls
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