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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 K961738
Device Name VIT COMMANDER SYSTEM
Applicant
Scieran Technologies, Inc.
27071 Cabot Rd., Suite 127
Laguna Hills,  CA  92653
Applicant Contact ROD ROSS
Correspondent
Scieran Technologies, Inc.
27071 Cabot Rd., Suite 127
Laguna Hills,  CA  92653
Correspondent Contact ROD ROSS
Regulation Number886.4150
Classification Product Code
HQE  
Subsequent Product Code
HQO  
Date Received05/03/1996
Decision Date 11/25/1996
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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