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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 K980085
Device Name PHACO COMMANDER
Applicant
SCIERAN TECHNOLOGIES, INC.
27071 CABOT RD., SUITE 127
LAGUNA HILLS,  CA  92653
Applicant Contact GARY S MOCNIK
Correspondent
SCIERAN TECHNOLOGIES, INC.
27071 CABOT RD., SUITE 127
LAGUNA HILLS,  CA  92653
Correspondent Contact GARY S MOCNIK
Regulation Number886.4670
Classification Product Code
HQC  
Date Received01/09/1998
Decision Date 02/24/1998
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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