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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 K914229
Device Name PHACO TIP
Applicant
Tri-Star Ophthalmic
P.O. Box 175
8105 Nebo Hills Rd.
Liberty,  MO  64068
Applicant Contact THOMAS M REYNOLDS
Correspondent
Tri-Star Ophthalmic
P.O. Box 175
8105 Nebo Hills Rd.
Liberty,  MO  64068
Correspondent Contact THOMAS M REYNOLDS
Regulation Number886.4670
Classification Product Code
HQC  
Date Received09/20/1991
Decision Date 12/27/1991
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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