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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K180315
Device Name DISKOM
Applicant
Biopsybell s.r.l.
Via A. Manuzio n.24
Mirandola,  IT 41037
Applicant Contact Tiziana Bellini
Correspondent
Isemed Srl
Via P. Togliatti 19/X
Imola,  IT 40026
Correspondent Contact Maurizio Pantaleoni
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/05/2018
Decision Date 03/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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