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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K013760
Device Name DC-3300 LASER DIODE PHOTOCOAGULATOR
Applicant
Nidek, Inc.
21911 Erie Ln.
Lake Forest,  CA  92630
Applicant Contact CAROL PATTERSON
Correspondent
Nidek, Inc.
21911 Erie Ln.
Lake Forest,  CA  92630
Correspondent Contact CAROL PATTERSON
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received11/13/2001
Decision Date 02/11/2002
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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