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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Battery-Powered
510(k) Number K083428
Device Name F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
Applicant
FIAB SPA
VIA COSTOLI, 4
VICCHIO
FIRENZE,  IT 50039
Applicant Contact SILVIA CALABRO
Correspondent
FIAB SPA
VIA COSTOLI, 4
VICCHIO
FIRENZE,  IT 50039
Correspondent Contact SILVIA CALABRO
Regulation Number886.4115
Classification Product Code
HQP  
Date Received11/19/2008
Decision Date 09/01/2009
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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