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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 K230287
Device Name SaviSafe Safety Device
Applicant
Suzhou Savicred Biotechnology Co., Ltd.
105-2 Block 1 #9 Su Hong W. Rd. Sip
Suzhou,  CN 215000
Applicant Contact Jiajun Zhu
Correspondent
Icas Group
155 Pingbei Rd., Minghang
Shanghai,  CN 201100
Correspondent Contact Ryan Li
Regulation Number880.5860
Classification Product Code
MEG  
Date Received02/02/2023
Decision Date 11/21/2023
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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