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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K161255
Device Name meso-relle (AAL34, AAL36, AM30G)
Applicant
Biotekne Srl
Via Della Bastia 9
Casalecchio Di Reno,  IT 40033
Applicant Contact Fabio Tassi
Correspondent
Studio DI Ingegneria Enrico Bisson
Via Marzia 9
Abano Terme,  IT 35031
Correspondent Contact Enrico Bisson
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/03/2016
Decision Date 01/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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