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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Fluid, Non-Electrically Powered
510(k) Number K923326
Device Name OPHTHALMIC VISCOINJECTOR DRIVE
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 Number880.5430
Classification Product Code
KZE  
Date Received07/07/1992
Decision Date 09/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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