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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K100053
Device Name MATTIOLI PULSE TWO/THREE PLUS FAMILY
Applicant
MATTIOLI ENGINEERING CORP.
8300 GREENSBORO DR.
SUITE 800
MCLEAN,  VA  22102
Applicant Contact GIANFRANCO BERNABEI
Correspondent
MATTIOLI ENGINEERING CORP.
8300 GREENSBORO DR.
SUITE 800
MCLEAN,  VA  22102
Correspondent Contact GIANFRANCO BERNABEI
Regulation Number878.4810
Classification Product Code
ONF  
Date Received01/08/2010
Decision Date 03/10/2010
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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