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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 K862777
Device Name MODEL A-8000 ULTRASONIC HANDPIECE CORD
Applicant
Advanced Medical Technology, Inc.
14 Hughes St., Suite B104
Irvine,  CA  92718
Applicant Contact THOMAS V KEELEY
Correspondent
Advanced Medical Technology, Inc.
14 Hughes St., Suite B104
Irvine,  CA  92718
Correspondent Contact THOMAS V KEELEY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/22/1986
Decision Date 08/11/1986
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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