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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 K884241
Device Name STAAR PHACO XL SMALL INCISION SYSTEM
Applicant
STAAR SURGICAL CO.
1911 WALKER AVE.
MONROVIA,  CA  91016
Applicant Contact SUZANNE RICHARDSON
Correspondent
STAAR SURGICAL CO.
1911 WALKER AVE.
MONROVIA,  CA  91016
Correspondent Contact SUZANNE RICHARDSON
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/11/1988
Decision Date 02/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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