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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 K834162
Device Name VIT PAC
Applicant
American Surgical Co., Inc.
Coventry,  RI 
Correspondent
American Surgical Co., Inc.
Coventry,  RI 
Regulation Number886.4150
Classification Product Code
HQE  
Date Received10/14/1983
Decision Date 02/07/1986
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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