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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 K972253
Device Name P3 UNIVERSAL PHACO HANDPIECE
Applicant
ODYSSEY TECHNOLOGIES, INC.
9327 BLACKLEY ST.
TEMPLE CITY,  CA  91780
Applicant Contact GLENN A DUNKI-JACOBS
Correspondent
ODYSSEY TECHNOLOGIES, INC.
9327 BLACKLEY ST.
TEMPLE CITY,  CA  91780
Correspondent Contact GLENN A DUNKI-JACOBS
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/16/1997
Decision Date 07/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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