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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 K930842
Device Name THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE
Applicant
Grieshaber & Co.
1945 Vaughn Rd.
P.O. Box 440609
Kennesaw,  GA  30144
Applicant Contact FRANK J TIGHE
Correspondent
Grieshaber & Co.
1945 Vaughn Rd.
P.O. Box 440609
Kennesaw,  GA  30144
Correspondent Contact FRANK J TIGHE
Regulation Number886.4150
Classification Product Code
HQE  
Date Received02/17/1993
Decision Date 05/03/1994
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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