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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 K972063
Device Name WHITTINGHAM ULTRACLEAN PHACO HANDPIECE
Applicant
William F. Whittingham
22 Flores
Foothill Ranch,  CA  92610
Applicant Contact WILLIAM F WHITTINGHAM
Correspondent
William F. Whittingham
22 Flores
Foothill Ranch,  CA  92610
Correspondent Contact WILLIAM F WHITTINGHAM
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/03/1997
Decision Date 11/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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