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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Engine, Trephine, Accessories, Ac-Powered
510(k) Number K013151
Device Name ASMOTOM AUTOMATED TREPHINE SYSTEM
Applicant
BKG OPTHALMICS USA, INC.
962 ALLEGRO LN.
APOLLO BEACH,  FL  33572
Applicant Contact ART WARD
Correspondent
BKG OPTHALMICS USA, INC.
962 ALLEGRO LN.
APOLLO BEACH,  FL  33572
Correspondent Contact ART WARD
Regulation Number886.4070
Classification Product Code
HRG  
Date Received09/20/2001
Decision Date 12/14/2001
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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