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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 K890080
Device Name PHACOEMULSIFIER MODEL 100
Applicant
Sonic Needle Corp.
1938 New Hwy.
Farmingdale,  NY  11735
Applicant Contact RALPH WERTHEIMER
Correspondent
Sonic Needle Corp.
1938 New Hwy.
Farmingdale,  NY  11735
Correspondent Contact RALPH WERTHEIMER
Regulation Number886.4670
Classification Product Code
HQC  
Date Received01/09/1989
Decision Date 04/06/1989
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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