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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K011939
Device Name FOTONA DUALIS, FOTONA DUALIS PLUS
Applicant
FOTONA D.D.
STEGNE 7,
LJUBLJANA,  SI 1210
Applicant Contact MOJCA VALJAVEC
Correspondent
FOTONA D.D.
STEGNE 7,
LJUBLJANA,  SI 1210
Correspondent Contact MOJCA VALJAVEC
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/21/2001
Decision Date 12/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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