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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 K851209
Device Name CILCO/UNITED SONICS PHACE PF-9000
Applicant
United Sonics, Inc.
180 Vanderbilt Motor Pkwy.
Hauppauge,  NY  11788
Applicant Contact JOSEPH SPINOSA
Correspondent
United Sonics, Inc.
180 Vanderbilt Motor Pkwy.
Hauppauge,  NY  11788
Correspondent Contact JOSEPH SPINOSA
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/26/1985
Decision Date 05/31/1985
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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