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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K221981
Device Name SafeR Syringe and SafeR Sting
Applicant
Roncadelle Operations Srl
Via Renolda 10
Castel Mella (Brescia),  IT 25030
Applicant Contact Massimo Rossi
Correspondent
Roncadelle Operations Srl
Via Renolda 10
Castel Mella (Brescia),  IT 25030
Correspondent Contact Massimo Rossi
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Codes
FMF   FMI  
Date Received07/05/2022
Decision Date 12/29/2022
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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