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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, Battery-Powered
510(k) Number K950056
Device Name THE GRIESHABER AXIAL CUTTER
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
HKP  
Date Received01/06/1995
Decision Date 05/05/1995
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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