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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
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