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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
510(k) Number K912112
Device Name PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480
Applicant
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Applicant Contact CARLA WAGGETT
Correspondent
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Correspondent Contact CARLA WAGGETT
Regulation Number886.4390
Classification Product Code
LQJ  
Date Received05/13/1991
Decision Date 06/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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