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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 K923725
Device Name OPHTHALMIC PHARCO NEEDLE
Applicant
Synergetics, Inc.
2019 Meadowbrook Way
Chesterfield,  MO  63017
Applicant Contact DONNA M SCHELLER
Correspondent
Synergetics, Inc.
2019 Meadowbrook Way
Chesterfield,  MO  63017
Correspondent Contact DONNA M SCHELLER
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/27/1992
Decision Date 03/18/1993
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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