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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K904612
Device Name I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
Applicant
Medical Technical Products
23042 Alcalde, Suite A
Laguna Hills,  CA  92653
Applicant Contact JAMES BAKOS
Correspondent
Medical Technical Products
23042 Alcalde, Suite A
Laguna Hills,  CA  92653
Correspondent Contact JAMES BAKOS
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/11/1990
Decision Date 12/26/1990
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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