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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K932668
Device Name OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
Applicant
Synergetics, Inc.
17466 Chesterfield Airport Rd.
Chesterfield,  MI 
Applicant Contact GREGG D SCHELLER
Correspondent
Synergetics, Inc.
17466 Chesterfield Airport Rd.
Chesterfield,  MI 
Correspondent Contact GREGG D SCHELLER
Regulation Number886.4150
Classification Product Code
HQE  
Date Received06/02/1993
Decision Date 02/23/1994
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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