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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intraocular Lens
510(k) Number K913626
Device Name SOFTRANS INJECTOR
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 Number886.3600
Classification Product Code
HQL  
Date Received08/15/1991
Decision Date 12/18/1991
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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