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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 K862021
Device Name PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM
Applicant
Ultramed, Inc.
13117 Quate Ct.
P.O. Box 27-135
Poway,  CA  92064
Applicant Contact MICHAEL, RPH
Correspondent
Ultramed, Inc.
13117 Quate Ct.
P.O. Box 27-135
Poway,  CA  92064
Correspondent Contact MICHAEL, RPH
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/28/1986
Decision Date 06/23/1986
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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